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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">Front. Neurol.</journal-id>
<journal-title>Frontiers in Neurology</journal-title>
<abbrev-journal-title abbrev-type="pubmed">Front. Neurol.</abbrev-journal-title>
<issn pub-type="epub">1664-2295</issn>
<publisher>
<publisher-name>Frontiers Media S.A.</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="doi">10.3389/fneur.2025.1631275</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Neurology</subject>
<subj-group>
<subject>Review</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>Measuring severe stroke: a scoping review of RCTs</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name><surname>Roesner</surname> <given-names>Katrin</given-names></name>
<xref ref-type="aff" rid="aff1"><sup>1</sup></xref>
<xref ref-type="aff" rid="aff2"><sup>2</sup></xref>
<xref ref-type="corresp" rid="c001"><sup>&#x002A;</sup></xref>
<xref ref-type="author-notes" rid="fn0002"><sup>&#x2020;</sup></xref>
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<contrib contrib-type="author">
<name><surname>Brodowski</surname> <given-names>Hanna</given-names></name>
<xref ref-type="aff" rid="aff1"><sup>1</sup></xref>
<xref ref-type="author-notes" rid="fn0003"><sup>&#x2020;</sup></xref>
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<contrib contrib-type="author">
<name><surname>Strutz</surname> <given-names>Nicole</given-names></name>
<xref ref-type="aff" rid="aff3"><sup>3</sup></xref>
<xref ref-type="author-notes" rid="fn0004"><sup>&#x2020;</sup></xref>
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<aff id="aff1"><sup>1</sup><institution>Department of Physiotherapy, Pain and Exercise Research Luebeck, Institute of Health Sciences, Universit&#x00E4;t zu L&#x00FC;beck</institution>, <addr-line>L&#x00FC;beck</addr-line>, <country>Germany</country></aff>
<aff id="aff2"><sup>2</sup><institution>International Graduate Academy, Institute of Health and Nursing Sciences, Medical Faculty of Martin Luther University Halle-Wittenberg, University Medicine Halle</institution>, <addr-line>Halle (Saale)</addr-line>, <country>Germany</country></aff>
<aff id="aff3"><sup>3</sup><institution>Department of Orthopedic and Trauma Surgery, Martin-Luther-University Halle-Wittenberg</institution>, <addr-line>Halle (Saale)</addr-line>, <country>Germany</country></aff>
<author-notes>
<fn fn-type="edited-by" id="fn0005">
<p>Edited by: Mostafa Meshref, Al-Azhar University, Egypt</p></fn>
<fn fn-type="edited-by" id="fn0006">
<p>Reviewed by: Maha AbuZarifa, Al-Quds University, Palestine</p>
<p>Abdallah Khatatbeh, King Hussein Medical Center, Jordan</p></fn>
<corresp id="c001">&#x002A;Correspondence: Katrin Roesner, <email>katrin.roesner@uni-luebeck.de</email></corresp>
<fn fn-type="other" id="fn0002"><p><sup>&#x2020;</sup>ORCID: Katrin Roesner, <ext-link ext-link-type="uri" xlink:href="https://orcid.org/0000-0001-5700-3374">https://orcid.org/0000-0001-5700-3374</ext-link></p></fn>
<fn fn-type="other" id="fn0003"><p>Hanna Brodowski, <ext-link ext-link-type="uri" xlink:href="https://orcid.org/0000-0002-7930-241X">https://orcid.org/0000-0002-7930-241X</ext-link></p></fn>
<fn fn-type="other" id="fn0004"><p>Nicole Strutz, <ext-link ext-link-type="uri" xlink:href="https://orcid.org/0000-0002-4780-2188">https://orcid.org/0000-0002-4780-2188</ext-link></p></fn>
</author-notes>
<pub-date pub-type="epub">
<day>30</day>
<month>07</month>
<year>2025</year>
</pub-date>
<pub-date pub-type="collection">
<year>2025</year>
</pub-date>
<volume>16</volume>
<elocation-id>1631275</elocation-id>
<history>
<date date-type="received">
<day>19</day>
<month>05</month>
<year>2025</year>
</date>
<date date-type="accepted">
<day>07</day>
<month>07</month>
<year>2025</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright &#x00A9; 2025 Roesner, Brodowski and Strutz.</copyright-statement>
<copyright-year>2025</copyright-year>
<copyright-holder>Roesner, Brodowski and Strutz</copyright-holder>
<license xlink:href="http://creativecommons.org/licenses/by/4.0/">
<p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.</p>
</license>
</permissions>
<abstract>
<sec id="sec1">
<title>Background</title>
<p>Stroke severity affects length of hospital stay and functional recovery in rehabilitation. Therefore, establishing baseline data of stroke severity is a crucial step. In 2017, neurorehabilitation researchers met at the Stroke Recovery and Rehabilitation Roundtable (SRRR) to build a consensus on new standards for stroke recovery research. Core outcomes for measurement in stroke trials resulted in the recommendation that severe stroke should be assessed using the NIHSS. This scoping review aims to provide an overview of the variety of measurements used in clinical research to assess severe stroke.</p>
</sec>
<sec id="sec2">
<title>Methods</title>
<p>RCTs and CCTs were identified by searching PubMed, CENTRAL, SSCI, and ICTRP, covering articles published between January 2018 and September 2024. Peer-reviewed articles in English focusing on rehabilitative interventions and patients aged 18&#x202F;years or older who have been classified with a severe stroke. The articles included were analyzed according to used measurements and cut-off scores.</p>
</sec>
<sec id="sec3">
<title>Results</title>
<p>The initial search yielded 1,004 publications, of which 35 (3.6%) studies were deemed eligible. In total, 11 different measures were used to assess severe stroke. Most studies used the NIHSS (<italic>n</italic>&#x202F;=&#x202F;14), followed by mRS (<italic>n</italic>&#x202F;=&#x202F;6), the FMA upper extremity (<italic>n</italic>&#x202F;=&#x202F;4), the original FMA (<italic>n</italic>&#x202F;=&#x202F;4) and the (modified) BI (<italic>n</italic>&#x202F;=&#x202F;3). Seven different cut-off scores for the NIHSS were identified, with the scale being most frequently used in clinical settings.</p>
</sec>
<sec id="sec4">
<title>Conclusion</title>
<p>This review indicates substantial variability in measurements and a diverse range of cut-off scores. Consequently, comparability of patients&#x2019; baseline stroke severity across studies is limited. Given the fact that the NIHSS is only partially used, future efforts should focus on barriers and challenges using the NIHSS.</p>
</sec>
</abstract>
<kwd-group>
<kwd>stroke severity</kwd>
<kwd>outcome measure</kwd>
<kwd>cut-off scores</kwd>
<kwd>neurological rehabilitation</kwd>
<kwd>stroke phase</kwd>
<kwd>NIHSS</kwd>
</kwd-group>
<counts>
<fig-count count="5"/>
<table-count count="3"/>
<equation-count count="0"/>
<ref-count count="59"/>
<page-count count="12"/>
<word-count count="7748"/>
</counts>
<custom-meta-wrap>
<custom-meta>
<meta-name>section-at-acceptance</meta-name>
<meta-value>Neurorehabilitation</meta-value>
</custom-meta>
</custom-meta-wrap>
</article-meta>
</front>
<body>
<sec sec-type="intro" id="sec5">
<label>1</label>
<title>Introduction</title>
<p>Strokes affect more than one&#x202F;billion people worldwide and are the leading cause of disability and the second leading cause of death (<xref ref-type="bibr" rid="ref1">1</xref>). Post-stroke consequences can be reflected at every level of the International Classification of Functioning, Disability and Health (<xref ref-type="bibr" rid="ref2">2</xref>). Different standardized measurements address these domains, capturing the complex impact of stroke on function, activity, and participation. An important factor influencing stroke survivors&#x2019; outcomes is stroke severity (<xref ref-type="bibr" rid="ref3">3</xref>, <xref ref-type="bibr" rid="ref4">4</xref>). It is a key factor in hospital length of stay, which is one of the most important indicators for monitoring the utilization of hospital treatment (<xref ref-type="bibr" rid="ref5">5</xref>). Unfortunately, the definition of stroke severity, especially severe stroke, is not used uniformly, with a wide range of different measures found (<xref ref-type="bibr" rid="ref6 ref7 ref8">6&#x2013;8</xref>).</p>
<p>In 2017, the measurement working group of the &#x2018;Stroke Recovery and Rehabilitation Roundtable&#x2019; (SRRR) was established to develop standardized recommendations and establish guidelines for standardized measuring time points and metrics to be used in all adult stroke sensorimotor recovery research (<xref ref-type="bibr" rid="ref9">9</xref>). According to the SRRR, the &#x2018;National Institute of Health Stroke Scale&#x2019; (NIHSS) should be used as a baseline measurement to determine the severity of a stroke, providing a quantifiable measurement of post-stroke neurological impairments across domains as well as the severity of symptoms linked to cerebral infarcts (<xref ref-type="bibr" rid="ref9">9</xref>).</p>
<p>The NIHS Scale ranges between 0 and 42 points, with a higher score indicating a higher stroke severity. Based on the work of Brott et al., the most prevalent cut-off values of the NIHSS for defining stroke severity are labeled as mild (<xref ref-type="bibr" rid="ref1 ref2 ref3 ref4">1&#x2013;4</xref>), moderate (<xref ref-type="bibr" rid="ref5 ref6 ref7 ref8 ref9 ref10 ref11 ref12 ref13 ref14">5&#x2013;14</xref>), severe (<xref ref-type="bibr" rid="ref15 ref16 ref17 ref18 ref19 ref20 ref21 ref22 ref23 ref24">15&#x2013;24</xref>) and very severe (25+) (<xref ref-type="bibr" rid="ref10">10</xref>). Briggs et al. used a cut-off score of &#x003E;16 points to define a severe stroke as well as &#x003E;20/42 (<xref ref-type="bibr" rid="ref11">11</xref>).</p>
<p>It is not known how the severity of stroke is currently classified in clinical research or whether they are measured using the recommended NIHSS. This scoping review aims to provide an overview of stroke severity measurements and cut-off scores used in clinical rehabilitation research.</p>
</sec>
<sec sec-type="methods" id="sec6">
<label>2</label>
<title>Methods</title>
<sec id="sec7">
<label>2.1</label>
<title>Study design</title>
<p>This scoping review was conducted according to the Joanna Briggs Institute guideline for scoping research and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement for reporting scoping (<xref ref-type="bibr" rid="ref12">12</xref>). The study protocol was pre-registered on the Open Science Framework Platform.<xref ref-type="fn" rid="fn0001"><sup>1</sup></xref></p>
</sec>
<sec id="sec8">
<label>2.2</label>
<title>Information sources and search strategy</title>
<p>Searches were conducted between January 2018 and September 2024 using a specified search string (<xref ref-type="table" rid="tab1">Table 1</xref>; <xref ref-type="supplementary-material" rid="SM1">Supplementary material</xref>). After an initial search, a comprehensive search strategy was developed and applied to MEDLINE via PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), the Social Sciences Citation Index (SSCI), and the International Clinical Trials Registry Platform (ICTRP).</p>
<table-wrap position="float" id="tab1">
<label>Table 1</label>
<caption>
<p>Search string.</p>
</caption>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th align="left" valign="top" colspan="4">MEDLINE via PubMed</th>
</tr>
</thead>
<tbody>
<tr>
<td align="left" valign="top">1 severe stroke[Title/Abstract]<break/>2 stroke severity[Title/Abstract]<break/>3 stroke disab&#x002A;[Title/Abstract]<break/>4 severe stroke impair&#x002A;[Title/Abstract]<break/>5 severe stroke limit&#x002A;[Title/Abstract]<break/>6 #1 OR #2 OR #3 OR #4 OR #5<break/>7 Autogenic Training[MeSH Terms]<break/>8 Combined Modality Therapy[MeSH Terms]<break/>9 Exercise Movement Techniques[MeSH Terms]<break/>10 Mentoring[MeSH Terms]<break/>11 Nursing Care[MeSH Terms]<break/>12 Patient Positioning[MeSH Terms]<break/>13 Stroke Rehabilitation[MeSH Terms]<break/>14 Teaching[MeSH Terms]<break/>15 Transcutaneous Electric Nerve Stimulation[MeSH Terms]</td>
<td align="left" valign="top">16 Video Games[MeSH Terms]<break/>17 Virtual Reality Exposure Therapy[MeSH Terms]<break/>18 aerobic exercise[Title/Abstract]<break/>19 aerobic training[Title/Abstract]<break/>20 biofeedback[Title/Abstract]<break/>21 coaching[Title/Abstract]<break/>22 cognitive behavioral therapy[Title/Abstract]<break/>23 cognitive rehabilitation[Title/Abstract]<break/>24 constraint induced therapy[Title/Abstract]<break/>25 education[Title/Abstract]<break/>26 electric stimulation therapy[Title/Abstract]<break/>27 exercise[Title/Abstract]<break/>28 exercise therapy[Title/Abstract]<break/>29 functional electric stimulation[Title/Abstract]<break/>30 health education[Title/Abstract]</td>
<td align="left" valign="top">31 home care[Title/Abstract]<break/>32 home rehabilitation[Title/Abstract]<break/>33 intensive care[Title/Abstract]<break/>34 mirror therapy[Title/Abstract]<break/>35 mobilization[Title/Abstract]<break/>36 motor relearning program[Title/Abstract]<break/>37 movement therapy[Title/Abstract]<break/>38 muscle training[Title/Abstract]<break/>39 neuromuscular electric stimulation[Title/Abstract]<break/>40 nursing[Title/Abstract]<break/>41 occupational therapy[Title/Abstract]<break/>42 patient education[Title/Abstract]<break/>43 physical activity[Title/Abstract]<break/>44 physical therapy modalities[Title/Abstract]<break/>45 physical therapy speciality[Title/Abstract]</td>
<td align="left" valign="top">46 robotics[Title/Abstract]<break/>47 task specific training[Title/Abstract]<break/>48 virtual reality[Title/Abstract]<break/>49 #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17<break/>OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27<break/>OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 OR #34 OR #35 OR #36 OR #37<break/>OR #38 OR #39 OR #40 OR #41 OR #42 OR #43 OR #44 OR #45 OR #46 OR #47<break/>OR #48<break/>50 #6 AND #49<break/>51 #50 (Filter: Randomized Controlled Trial)<break/>52 #51 (Filter: Date - Publication 01.01.2018 to 06.09)</td>
</tr>
</tbody>
</table>
</table-wrap>
</sec>
<sec id="sec9">
<label>2.3</label>
<title>Inclusion/exclusion criteria</title>
<p>All RCTs and CCTs published in peer-reviewed journals enrolled severe stroke patients aged &#x2265;18&#x202F;years undergoing a rehabilitative intervention (e.g., physiotherapy, speech-language therapy, occupational therapy, nursing, and neuropsychology) were included. Articles were excluded if they used pharmacological and surgical interventions, non-invasive brain stimulation and complementary or alternative medicine interventions. If one or more secondary analyses were published, it was checked whether the primary study had already been included, if not, the first publication of a secondary analysis was included.</p>
</sec>
<sec id="sec10">
<label>2.4</label>
<title>Study selection</title>
<p>The Rayyan management software (Rayyan Systems Inc., Cambridge, MA 02142, United States) was used to select the included articles (<xref ref-type="bibr" rid="ref13">13</xref>). Two reviewers (KR, LK) independently screened titles and abstracts to exclude those that did not meet the inclusion criteria. In a second step, the same two researchers independently performed a full-text screening of the remaining studies etiology. Disagreements during the entire process were discussed with a third researcher (NS) until consensus was reached.</p>
</sec>
<sec id="sec11">
<label>2.5</label>
<title>Data extraction</title>
<p>The data from each included study was extracted by KR and HB, using a data extraction framework. Conflicts were resolved by discussion with NS. According to the definition of scoping reviews, the methodological quality of the included studies was not evaluated. Following the JBI methodology for scoping reviews, a formal appraisal of methodological quality was not required (<xref ref-type="bibr" rid="ref14">14</xref>).</p>
<p>Stroke severity measurement tools used in the included studies were grouped according to the International Classification of Functioning, Disability and Health into body function and body structures, activities, and participation (<xref ref-type="bibr" rid="ref15">15</xref>).</p>
</sec>
</sec>
<sec sec-type="results" id="sec12">
<label>3</label>
<title>Results</title>
<p>In total, 1,004 articles were identified for screening. After screening titles and abstracts, 646 articles were excluded due to exclusion criteria like pharmacological therapy or congress contribution without conclusive results. A total of 358 references remained and were screened for inclusion. The complete process for the inclusion of the final 35 publications is depicted in the PRISMA flow chart (<xref ref-type="fig" rid="fig1">Figure 1</xref>).</p>
<fig position="float" id="fig1">
<label>Figure 1</label>
<caption>
<p>Study selection flow chart according to PRISMA 2020.</p>
</caption>
<graphic xlink:href="fneur-16-1631275-g001.tif">
<alt-text content-type="machine-generated">Flowchart illustrating the selection process of studies for inclusion in a review. From databases and registers, 1,210 records were identified, with 206 duplicates removed before screening. From other methods, 5 records were identified. After screening, 646 records were excluded. Of 358 reports sought for retrieval, all were obtained. 358 reports were assessed for eligibility, with several exclusions due to various reasons (e.g., no severity measure, mild-moderate stroke). Finally, 35 studies and 7 reports were included in the review.</alt-text>
</graphic>
</fig>
<sec id="sec13">
<label>3.1</label>
<title>Description of included studies</title>
<p>Out of 1,004 articles screened, 35 articles were included. Geographically, most of the studies were conducted in Europe (38%), followed by America (24%), Asia (24%), and Australia (14%). Participants were recruited in various settings, which were categorized into three groups. Starting with the clinical setting (<italic>n</italic>&#x202F;=&#x202F;15) and the rehabilitation setting (<italic>n</italic>&#x202F;=&#x202F;14). The term &#x201C;non-clinical/rehabilitative setting&#x201D; (<italic>n</italic>&#x202F;=&#x202F;10) was used to categorize various settings&#x2014;such as laboratory or community settings&#x2014;that did not align with either of the two primary categories. In two studies (<xref ref-type="bibr" rid="ref16">16</xref>, <xref ref-type="bibr" rid="ref17">17</xref>) participants were recruited in two settings. In the studies by Mulder et al. (<xref ref-type="bibr" rid="ref18">18</xref>) and Sakakibara et al. (<xref ref-type="bibr" rid="ref19">19</xref>), participants were recruited from three different settings. Salazar et al. (<xref ref-type="bibr" rid="ref20">20</xref>) did not provide any information about the setting.</p>
<p>Within these studies, participants were mostly included during the early subacute phase (<italic>n</italic>&#x202F;=&#x202F;13), followed by chronic stroke phase (<italic>n</italic>&#x202F;=&#x202F;8), hyperacute stroke phase (<italic>n</italic>&#x202F;=&#x202F;8), late subacute (<italic>n</italic>&#x202F;=&#x202F;3), and acute (<italic>n</italic>&#x202F;=&#x202F;2). For two of these studies, the stroke phase was not specified.</p>
<p>Most interventions involved physical activation, including specific exercises, training programs, or early mobilization. Additionally, many interventions incorporated robotic-assisted technologies or other digital health solutions, such as mobile applications, health platforms, or virtual reality. Several studies implemented transcranial stimulation and brain-computer interfaces as part of the intervention. A smaller proportion received video-based education or adherence-enhancing strategies. Most of the control group received conventional therapy, standard hospital care, and home exercise program for the clinic or rehabilitation facility (<xref ref-type="table" rid="tab2">Table 2</xref>).</p>
<table-wrap position="float" id="tab2">
<label>Table 2</label>
<caption>
<p>Included studies, settings, stroke phases, stroke severity measurements and interventions of RCTs and CCTs.</p>
</caption>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th align="left" valign="top">Author, date, location</th>
<th align="center" valign="top"><italic>n</italic></th>
<th align="left" valign="top">Setting</th>
<th align="left" valign="top">Phase</th>
<th align="left" valign="top">Measurement</th>
<th align="left" valign="top">Intervention</th>
</tr>
</thead>
<tbody>
<tr>
<td align="left" valign="top">Aguiar et al. (2020) (<xref ref-type="bibr" rid="ref25">25</xref>)<break/>Brazil, Canada</td>
<td align="center" valign="top">22</td>
<td align="left" valign="top">Non clinical/rehab</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">FMA-UL<break/>FMA-LL</td>
<td align="left" valign="top">IG: aerobic treadmill training<break/>CG: outdoor-overground walking</td>
</tr>
<tr>
<td align="left" valign="top">Aprile et al. (2020) (<xref ref-type="bibr" rid="ref47">47</xref>)<break/>Italy</td>
<td align="center" valign="top">247</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early and late subacute</td>
<td align="left" valign="top">FMA-UL</td>
<td align="left" valign="top">IG: robotic and sensor-based device<break/>CG: conventional treatment:</td>
</tr>
<tr>
<td align="left" valign="top">Brunner et al. (2024) (<xref ref-type="bibr" rid="ref29">29</xref>)<break/>Denmark</td>
<td align="center" valign="top">40</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: sessions with Brain-Computer Interfaces<break/>CG: standard physiotherapy and occupational therapy</td>
</tr>
<tr>
<td align="left" valign="top">Buvarp et al. (2023) (<xref ref-type="bibr" rid="ref42">42</xref>)<break/>Sweden</td>
<td align="center" valign="top">1.367</td>
<td align="left" valign="top">Clinical, rehab</td>
<td align="left" valign="top">Hyperacute, acute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: increased physical activity<break/>CG: decreased physical activity</td>
</tr>
<tr>
<td align="left" valign="top">Chen et al. (2021) (<xref ref-type="bibr" rid="ref27">27</xref>)<break/>China</td>
<td align="center" valign="top">96</td>
<td align="left" valign="top">Non clinical/rehab</td>
<td align="left" valign="top">Acute</td>
<td align="left" valign="top">BI</td>
<td align="left" valign="top">IG: goal-oriented Intervention<break/>CG: health education</td>
</tr>
<tr>
<td align="left" valign="top">Conroy et al. (2019) (<xref ref-type="bibr" rid="ref24">24</xref>)<break/>United States</td>
<td align="center" valign="top">45</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">FMA</td>
<td align="left" valign="top">IG: robot-assisted arm training<break/>CG: therapist-assisted<break/>task training</td>
</tr>
<tr>
<td align="left" valign="top">Cumming et al. (2018, 2019) (<xref ref-type="bibr" rid="ref48">48</xref>, <xref ref-type="bibr" rid="ref49">49</xref>), Walters et al. (2020) (<xref ref-type="bibr" rid="ref50">50</xref>), Bernhardt et al. (2021) (<xref ref-type="bibr" rid="ref51">51</xref>) United Kingdom, Australia, South East Asia</td>
<td align="center" valign="top">2.104</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Hyperacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: very early and more frequent mobilization<break/>CG: usual care</td>
</tr>
<tr>
<td align="left" valign="top">De Bruyn et al. (2020) (<xref ref-type="bibr" rid="ref30">30</xref>)<break/>Belgium</td>
<td align="center" valign="top">40</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">FMA</td>
<td align="left" valign="top">IG: sensorimotor therapy (SENSe approach) and task specific exercises<break/>CG: cognitive table-top games with the non-affected UL and 30&#x202F;min task-specific motor exercises</td>
</tr>
<tr>
<td align="left" valign="top">De Jong et al. (2018) (<xref ref-type="bibr" rid="ref52">52</xref>)<break/>United Kingdom, Netherlands</td>
<td align="center" valign="top">46</td>
<td/>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">FMA-UL</td>
<td align="left" valign="top">IG: PT therapy as recommended by the Dutch stroke guideline<break/>CG: OT therapy as recommended by the Dutch stroke guideline</td>
</tr>
<tr>
<td align="left" valign="top">Ertas-Spantgar et al. (2024) (<xref ref-type="bibr" rid="ref28">28</xref>)<break/>Germany</td>
<td align="center" valign="top">24</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Post-acute</td>
<td align="left" valign="top">BI</td>
<td align="left" valign="top">IG: usual therapy and experimental therapy by RehaGoal App<break/>CG: usual therapy</td>
</tr>
<tr>
<td align="left" valign="top">Frange et al. (2023) (<xref ref-type="bibr" rid="ref21">21</xref>)<break/>Brazil</td>
<td align="center" valign="top">8</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Hyperacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: performing calf muscle contractions by activity<break/>CG: inactivity</td>
</tr>
<tr>
<td align="left" valign="top">Kamal et al. (2020) (<xref ref-type="bibr" rid="ref43">43</xref>)<break/>Pakistan</td>
<td align="center" valign="top">310</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Acute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: video-based education intervention<break/>CG: standard care</td>
</tr>
<tr>
<td align="left" valign="top">Kersey et al. (2023) (<xref ref-type="bibr" rid="ref16">16</xref>)<break/>United States</td>
<td align="center" valign="top">32</td>
<td align="left" valign="top">CLINICAL and non clinical/rehab</td>
<td align="left" valign="top">Hyperacute, acute, early subacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: patients receive strategy training using a mobile health platform (iADAPT)<break/>CG: patients receive strategy training using a workbook</td>
</tr>
<tr>
<td align="left" valign="top">Kim et al. (2020) (<xref ref-type="bibr" rid="ref53">53</xref>)<break/>Korea</td>
<td align="center" valign="top">21</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Late subacute</td>
<td align="left" valign="top">FAC</td>
<td align="left" valign="top">IG: underwater gait training<break/>CG: overground gait training</td>
</tr>
<tr>
<td align="left" valign="top">Koo et al. (2018) (<xref ref-type="bibr" rid="ref31">31</xref>)<break/>Korea</td>
<td align="center" valign="top">24</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">mBI</td>
<td align="left" valign="top">IG: anodal transcranial direct current stimulation<break/>CG: sham stimulation</td>
</tr>
<tr>
<td align="left" valign="top">Logan et al. (2022) (<xref ref-type="bibr" rid="ref54">54</xref>)<break/>England</td>
<td align="center" valign="top">45</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Hyperacute, acute</td>
<td align="left" valign="top">mRS</td>
<td align="left" valign="top">IG: functional standing frame program<break/>CG: usual physiotherapy</td>
</tr>
<tr>
<td align="left" valign="top">Le Franc et al. (2021) (<xref ref-type="bibr" rid="ref55">55</xref>)<break/>France</td>
<td align="center" valign="top">20</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">FMA-UL</td>
<td align="left" valign="top">IG: tendor vibration and visual feedback; severe stroke group<break/>CG: tendor vibration and visual feedback; mild to moderate stroke group</td>
</tr>
<tr>
<td align="left" valign="top">Mahmood et al. (2022) (<xref ref-type="bibr" rid="ref17">17</xref>)<break/>India</td>
<td/>
<td align="left" valign="top">Rehab and non-clinical/rehab</td>
<td align="left" valign="top">Early subacute, chronic</td>
<td align="left" valign="top">FMA</td>
<td align="left" valign="top">IG: received additional adherence strategies<break/>CG: standard hospital care and home exercise program</td>
</tr>
<tr>
<td align="left" valign="top">Martins et al. (2020) (<xref ref-type="bibr" rid="ref32">32</xref>)<break/>Brazil, Canada</td>
<td align="center" valign="top">26</td>
<td align="left" valign="top">Nonclinical/rehab</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">FMA-UL<break/>FMA-LL</td>
<td align="left" valign="top">IG: task-specific circuit training<break/>CG: standard care</td>
</tr>
<tr>
<td align="left" valign="top">Middleton et al. (2019) (<xref ref-type="bibr" rid="ref56">56</xref>)<break/>Australia</td>
<td align="center" valign="top">970</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Hyperacute to acute</td>
<td align="left" valign="top">LAMS</td>
<td align="left" valign="top">IG: Intervention stroke units with treatment protocols<break/>CG: Control group stroke units</td>
</tr>
<tr>
<td align="left" valign="top">Mulder et al. (2022) (<xref ref-type="bibr" rid="ref18">18</xref>)<break/>Australia, Netherlands</td>
<td align="center" valign="top">129</td>
<td align="left" valign="top">Clinical, rehab and non-clinical/rehab</td>
<td align="left" valign="top">Early and late subacute</td>
<td align="left" valign="top">mRS</td>
<td align="left" valign="top">IG: 8-week caregiver-mediated exercises intervention<break/>CG: control intervention</td>
</tr>
<tr>
<td align="left" valign="top">Nagai et al. (2024) (<xref ref-type="bibr" rid="ref57">57</xref>)<break/>Japan</td>
<td align="center" valign="top">42</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">n.n.</td>
<td align="left" valign="top">mRS<break/>FIM motor item</td>
<td align="left" valign="top">IG: standing on unstable board for the nonparalyzed lower limbs<break/>CG: usual physical therapy</td>
</tr>
<tr>
<td align="left" valign="top">Ouyang et al. (2020, 2021) (<xref ref-type="bibr" rid="ref44">44</xref>, <xref ref-type="bibr" rid="ref58">58</xref>) China, United Kingdom, Australia, India, Sri Lanka</td>
<td align="center" valign="top">11.084</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Hyperacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: sitting up head position<break/>CG: lying flat</td>
</tr>
<tr>
<td align="left" valign="top">Radford et al. (2020) (<xref ref-type="bibr" rid="ref22">22</xref>)<break/>n.n.</td>
<td align="center" valign="top">46</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">n.n.</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: vocational rehabilitation<break/>CG: usual care</td>
</tr>
<tr>
<td align="left" valign="top">Renner et al. (2020) (<xref ref-type="bibr" rid="ref59">59</xref>)<break/>Germany</td>
<td align="center" valign="top">69</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Late subacute</td>
<td align="left" valign="top">FMA-UL<break/>MRC</td>
<td align="left" valign="top">IG: bilateral training<break/>CG: unilateral training</td>
</tr>
<tr>
<td align="left" valign="top">Reynolds et al. (2021) (<xref ref-type="bibr" rid="ref33">33</xref>)<break/>Australia</td>
<td align="center" valign="top">20</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">NIHSS<break/>mRS</td>
<td align="left" valign="top">IG: moderate-intensity fitness training<break/>CG: low-intensity exercise</td>
</tr>
<tr>
<td align="left" valign="top">Rose et al. (2022) (<xref ref-type="bibr" rid="ref34">34</xref>)<break/>Australia, New Zealand</td>
<td align="center" valign="top">116</td>
<td align="left" valign="top">Non-clinical/rehab</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">mRS</td>
<td align="left" valign="top">IG: Aphasia Therapies CIAT-Plus or M-MAT<break/>CG: usual care</td>
</tr>
<tr>
<td align="left" valign="top">Sakakibara et al. (2022) (<xref ref-type="bibr" rid="ref19">19</xref>) Canada</td>
<td align="center" valign="top">126</td>
<td align="left" valign="top">Clinical, rehab and Non-clinical/rehab</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">mRS</td>
<td align="left" valign="top">IG: Stroke Coach<break/>CG: Memory Training group</td>
</tr>
<tr>
<td align="left" valign="top">Salazar et al. (2024) (<xref ref-type="bibr" rid="ref20">20</xref>)<break/>United States</td>
<td align="center" valign="top">20</td>
<td align="left" valign="top">n. n.</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: transcranial direct current stimulation<break/>CG: sham during image acquisition</td>
</tr>
<tr>
<td align="left" valign="top">Smith et al. (2021) (<xref ref-type="bibr" rid="ref45">45</xref>)<break/>United States</td>
<td align="center" valign="top">23</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: bimanual lever-driven wheelchair<break/>CG: Conventional exercise group</td>
</tr>
<tr>
<td align="left" valign="top">Stockbridge et al. (2023) (<xref ref-type="bibr" rid="ref35">35</xref>)<break/>United States</td>
<td align="center" valign="top">51</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Chronic</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: transcranial direct current stimulation (tDCS)<break/>CG: standard care</td>
</tr>
<tr>
<td align="left" valign="top">Straudi et al. (2020) (<xref ref-type="bibr" rid="ref26">26</xref>)<break/>Italy</td>
<td align="center" valign="top">39</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">FMA-LL</td>
<td align="left" valign="top">IG: robot-assisted arm therapy and hand functional electrical stimulation<break/>CG: time-matched intensive conventional therapy</td>
</tr>
<tr>
<td align="left" valign="top">Threapleton et al. (2020) (<xref ref-type="bibr" rid="ref23">23</xref>) United Kingdom</td>
<td align="center" valign="top">33</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">All phases</td>
<td align="left" valign="top">NIHSS<break/>OSCPS</td>
<td align="left" valign="top">IG: virtual reality intervention<break/>CG: usual care</td>
</tr>
<tr>
<td align="left" valign="top">Tistad et al. (2018) (<xref ref-type="bibr" rid="ref36">36</xref>) Sweden</td>
<td align="center" valign="top">237</td>
<td align="left" valign="top">Rehab</td>
<td align="left" valign="top">Early subacute</td>
<td align="left" valign="top">BI</td>
<td align="left" valign="top">IG: client-centered activities of daily living intervention<break/>CG: usual activities of daily living intervention</td>
</tr>
<tr>
<td align="left" valign="top">Watkins et al. (2022) (<xref ref-type="bibr" rid="ref37">37</xref>)<break/>United Kingdom</td>
<td align="center" valign="top">157</td>
<td align="left" valign="top">Clinical</td>
<td align="left" valign="top">Hyperacute</td>
<td align="left" valign="top">NIHSS</td>
<td align="left" valign="top">IG: systematic voiding program for urinary incontinence<break/>CG: usual care</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<p>BI, Barthel Index; CG, control group; FAC, Functional Ambulation Categories; FMA, Fugl-Meyer-Assessment; FMA-UL, Fugl-Meyer-Assessment upper extremity; FMA LL, Fugl-Meyer-Assessment lower extremity; IG, intervention group; LAMS, Los Angeles Motor Scale; mBI, Modified Barthel Index; mRS, modified Rankin Scale; NIHSS, National Institute Stroke Scale; OCSPC, Oxfordshire Community Stroke Project Classification.</p>
</table-wrap-foot>
</table-wrap>
</sec>
<sec id="sec14">
<label>3.2</label>
<title>Identified measures and framework conditions</title>
<p>Eleven different measures were used to assess stroke severity (<xref ref-type="table" rid="tab3">Table 3</xref>). Most studies used the NIHSS (<italic>n</italic>&#x202F;=&#x202F;14), followed by modified Rankin Scale (<italic>n</italic>&#x202F;=&#x202F;6). The Fugl-Meyer-Assessment for the upper extremity (FMA-UL), and the original Fugl-Meyer-Assessment (FMA), were each used four times to address stroke severity. The Barthel Index (BI) was used in three studies, and the Functional Ambulation Categories (FAC) and the Los Angeles Motor Scale (LAMS) was used in one study. Six studies included two measures to assess stroke severity. The NIHSS was used in seven studies to identify the hyperacute phase.</p>
<table-wrap position="float" id="tab3">
<label>Table 3</label>
<caption>
<p>Overview Stroke Measurements and ICF categories; <italic>n</italic>=11</p>
</caption>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th align="left" valign="middle"><bold>Instrument of Measurement (abbrev.)</bold></th>
<th align="center" valign="middle"><bold>Original authors</bold></th>
<th align="center" valign="middle"><bold>Method of report</bold></th>
<th align="center" valign="middle"><bold>Components</bold></th>
<th align="center" valign="middle"><bold>Scoring system</bold></th>
<th align="center" valign="middle"><bold>Validation studies</bold></th>
</tr>
</thead>
<tbody>
<tr>
<td align="left" valign="top">National Institute of Health Stroke Scale (NIHSS)</td>
<td align="left" valign="top">Brott, T., Adams, H. P., Jr, Olinger, C. P., Marler, J. R., Barsan, W. G., Biller, J., Spilker, J., Holleran, R., Eberle, R., &#x0026; Hertzberg, V. (1989). Measurements of acute cerebral infarction: a clinical examination scale. Stroke, 20(7), 864&#x2013;870. https://doi.org/10.1161/01.str.20.7.864</td>
<td align="left" valign="top">Observer<break/>Paper and Pencil</td>
<td align="left" valign="top">15 Items<break/>Aphasia,<break/>Behavior,<break/>Cognition,<break/>Dysarthria,<break/>Vision<break/>Perception</td>
<td align="left" valign="top">0 - 3 and 0 - 4 ordinal scale with written and numerical descriptors.<break/>Calculation of a total score 0 - 42. Higher scores indicate greater severity.</td>
<td align="left" valign="top">Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864. PMID: 2749846.</td>
</tr>
<tr>
<td align="left" valign="top">Fugl-Meyer-Assessment (FMA)</td>
<td align="left" valign="top">Fugl-Meyer, A. R., J&#x00E4;&#x00E4;sk&#x00F6;, L., Leyman, I., Olsson, S., &#x0026; Steglind, S. (1975). The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. <italic>Scandinavian journal of rehabilitation medicine</italic>, <italic>7</italic>(1), 13&#x2013;31.</td>
<td align="left" valign="top">Observer<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">155 Items<break/>Activities of daily linving,<break/>Functional Mobility,<break/>Pain<break/>Five domains (Motor function, Sensory function, Balance, Joint range of Motion, Joint pain),</td>
<td align="left" valign="top">0 - 3 ordinal scale<break/>Calculation of a total score 0 &#x2013; 226</td>
<td align="left" valign="top">Fugl-Meyer AR et al.: The post-stroke hemiplegic patient. A method for evaluation of physical performance. Scand J Rehabil Med 1975, 7:13-31</td>
</tr>
<tr>
<td align="left" valign="top">Fugl-Meyer upper extremity (FM UE) (as part of the FMA)</td>
<td align="left" valign="top">Fugl-Meyer, A. R., J&#x00E4;&#x00E4;sk&#x00F6;, L., Leyman, I., Olsson, S., &#x0026; Steglind, S. (1975). The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. <italic>Scandinavian journal of rehabilitation medicine</italic>, <italic>7</italic>(1), 13&#x2013;31.</td>
<td align="left" valign="top">Observer<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">A - Shoulder/Elbow /Forearm<break/>B &#x2013; Wrist<break/>C &#x2013; Hand<break/>D &#x2013; Coordination/ Speed</td>
<td align="left" valign="top">0 - 3 ordinal scale<break/>Calculation of a total score<break/>0 - 66</td>
<td align="left" valign="top">Fugl-Meyer AR et al.: The post-stroke hemiplegic patient. A method for evaluation of physical performance. Scand J Rehabil Med 1975, 7:13-31</td>
</tr>
<tr>
<td align="left" valign="top">Fugl-Meyer lower extremity (FM LE) (as part of the FMA)</td>
<td align="left" valign="top">Fugl-Meyer, A. R., J&#x00E4;&#x00E4;sk&#x00F6;, L., Leyman, I., Olsson, S., &#x0026; Steglind, S. (1975). The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. <italic>Scandinavian journal of rehabilitation medicine</italic>, <italic>7</italic>(1), 13&#x2013;31.</td>
<td align="left" valign="top">Observer<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">E &#x2013; Hip/Knee/Ancle<break/>F &#x2013; Coordination/ Speed<break/>G - Balance</td>
<td align="left" valign="top">0 - 3 ordinal scale<break/>Calculation of a total score 0 - 34</td>
<td align="left" valign="top">Fugl-Meyer AR et al.: The post-stroke hemiplegic patient. A method for evaluation of physical performance. Scand J Rehabil Med 1975, 7:13-31</td>
</tr>
<tr>
<td align="left" valign="top">Barthel Index (BI)</td>
<td align="left" valign="top">Mahoney, F. I., &#x0026; Barthel, D. W. (1965). Functional evaluation: the barthel index. <italic>Maryland state medical journal</italic>, <italic>14</italic>, 61&#x2013;65.</td>
<td align="left" valign="top">Performance Measure<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">10 Items<break/>Activities of Daily Living<break/>Functional Mobility<break/>Gait</td>
<td align="left" valign="top">Items are rated based on the amount of assistance required to complete each activity, can choose between 0-5-10-15</td>
<td align="left" valign="top">Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. doi: 10.3109/09638288809164103. PMID: 3403500.</td>
</tr>
<tr>
<td align="left" valign="top">Modified Barthel Index (mBI)</td>
<td align="left" valign="top">Collin, C., Wade, D. T., Davies, S., &#x0026; Horne, V. (1988). The Barthel ADL Index: a reliability study. <italic>International disability studies</italic>, <italic>10</italic>(2), 61&#x2013;63. https://doi.org/10.3109/09638288809164103</td>
<td align="left" valign="top">Performance Measure<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">10 Items<break/>Activities of Daily Living<break/>Functional Mobility<break/>Gait</td>
<td align="left" valign="top">Items are rated based on the amount of assistance required to complete each activity</td>
<td align="left" valign="top">Shah, S, Vanley, F., Cooper, B. Improving the sensitivity of the Barthel Index for stroke rehabilitation<break/>https://doi.org/10.1016/0895-4356(89)90065-6</td>
</tr>
<tr>
<td align="left" valign="top">Modified Rankin Scale (mRS)</td>
<td align="left" valign="top">van Swieten, J. C., Koudstaal, P. J., Visser, M. C., Schouten, H. J., &#x0026; van Gijn, J. (1988). Interobserver agreement for the assessment of handicap in stroke patients. <italic>Stroke</italic>, <italic>19</italic>(5), 604&#x2013;607. https://doi.org/10.1161/01.str.19.5.604</td>
<td align="left" valign="top">Observer</td>
<td align="left" valign="top">Single item</td>
<td align="left" valign="top">6-point rankin scale fom 0=no symptoms to 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention</td>
<td align="left" valign="top">Rankin, J. (1957). Cerebral vascular accidents in patients over the age of 60. <italic>Scott Med J</italic>, 2, 200-215.</td>
</tr>
<tr>
<td align="left" valign="top">Functional Ambulation Categories (FAC)</td>
<td align="left" valign="top">Holden M.K., Gill K.M., Magliozzi M.R., Nathan J., Piehl-Baker L. Clinical gait assessment in the neurologically impaired Reliability and meaningfulness. <italic>Phys Ther.</italic> 1984; 64: 35-40</td>
<td align="left" valign="top">Observer<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">Assessing walking ability in 6 broard categories</td>
<td align="left" valign="top">0-5<break/>Higher score indicates less dependency</td>
<td align="left" valign="top">Mehrholz, J., Wagner, K., Rutte, K., Meiner, D. and Pohl, M. Predictive validity and responsiveness of the Functional Ambulation Category in hemiparetic patients after stroke. Archives of Physical Medicine Rehabilitation, 2007, 88, 1314-1319.</td>
</tr>
<tr>
<td align="left" valign="top">Action Research Arm Test</td>
<td align="left" valign="top">Lyle R. C. (1981). A performance test for assessment of upper limb function in physical rehabilitation treatment and research. <italic>International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation</italic>, <italic>4</italic>(4), 483&#x2013;492. https://doi.org/10.1097/00004356-198112000-00001</td>
<td align="left" valign="top">Observer<break/>Paper &#x0026; Pencil</td>
<td align="left" valign="top">Activities of Daily Living,<break/>Coordination,<break/>Dexterity,<break/>Upper Extremity<break/>Function<break/>19 Items</td>
<td align="left" valign="top">4-point ordinal scale<break/>Calculation of a total score 0 - 57</td>
<td align="left" valign="top">Koh CL, Hsueh IP, Wang WC, Sheu CF, Yu TY, Wang CH, Hsieh CL. Validation of the action research arm test using item response theory in patients after stroke. J Rehabil Med. 2006 Nov;38(6):375-80. doi: 10.1080/16501970600803252. PMID: 17067971.<break/>Chen HF, Lin KC, Wu CY, Chen CL. Rasch validation and predictive validity of the action research arm test in patients receiving stroke rehabilitation. Arch Phys Med Rehabil. 2012 Jun;93(6):1039-45. doi: 10.1016/j.apmr.2011.11.033. Epub 2012 Mar 14. PMID: 22420887.</td>
</tr>
<tr>
<td align="left" valign="top">Oxfordshire Community Stroke<break/>Project Classification (OCSP)</td>
<td align="left" valign="top">Bamford, J., Sandercock, P., Dennis, M., Burn, J., &#x0026; Warlow, C. (1991). Classification and natural history of clinically identifiable subtypes of cerebral infarction. <italic>Lancet (London, England)</italic>, <italic>337</italic>(8756), 1521&#x2013;1526. https://doi.org/10.1016/0140-6736(91)93206-o</td>
<td/>
<td align="left" valign="top">classification of four sub-categories of cerebral infarction based on presenting symptoms and signs:</td>
<td align="left" valign="top">lacunar infarcts (LACI)<break/>total anterior circulation infarcts (TACI)<break/>partial anterior circulation infarcts (PACI)<break/>posterior circulation infarcts (POCI)</td>
<td align="left" valign="top">A prospective study of acute cerebrovascular disease in the community: the Oxfordshire Community Stroke Project 1981-86. 1. Methodology, demography and incident cases of first-ever stroke.J Neurol Neurosurg Psychiatry. 1988 Nov; 51(11): 1373&#x2013;1380.</td>
</tr>
<tr>
<td align="left" valign="top">Los Angeles Motor Scale (LAMS)</td>
<td align="left" valign="top">Llanes, J. N., Kidwell, C. S., Starkman, S., Leary, M. C., Eckstein, M., &#x0026; Saver, J. L. (2004). The Los Angeles Motor Scale (LAMS): a new measure to characterize stroke severity in the field. <italic>Prehospital emergency care</italic>, <italic>8</italic>(1), 46&#x2013;50. https://doi.org/10.1080/312703002806</td>
<td align="left" valign="top">Observer</td>
<td align="left" valign="top">3-item prehospital scoring tool<break/>Facial droop<break/>Arm drift<break/>Grip strength</td>
<td align="left" valign="top">0-1<break/>0=absent<break/>+1= present/drifts down, weak grip<break/>+2=falls rapidly/no grip</td>
<td align="left" valign="top">Kim JT, Chung PW, Starkman S, et al. Field Validation of the Los Angeles Motor Scale as a Tool for Paramedic Assessment of Stroke Severity. Stroke. 2017; 48(2): 298-306.<break/>Nazliel B., Starkman S, Liebeskind DS, et al. A brief prehospital stroke severity scale identifies ischemic stroke patients harboring perstisting large arteroa&#x00F6; occlusions. Stroke. 2008; 39(8): 2264-7.</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<p>A, Activity; BF, Body function; I, Impairment; ICF, International Classification of Functioning, Disability and Health; P, Participation.</p>
</table-wrap-foot>
</table-wrap>
<p>The original FMA was used in all three settings, mainly during the chronic phase, as well as the combination of FMA-UL and the Fugl-Meyer-Assessment of the lower extremity (FMA-LL) (n&#x202F;=&#x202F;3) and once during the early subacute phase. In contrast, the FMA-UL was used twice in a rehabilitation setting during early subacute and late subacute.</p>
<p>Most of the measures can be assigned to a single ICF level. The NIHSS, Oxfordshire Community Stroke Project Classification (OCSP), and Los Angeles Motor Scale (LAMS) correspond to body function and impairment. Only the FMA as well as FMA-UL and FMA-LL, and the Functional Independence Measure (FIM) motor items cover both body function and impairment as well as the activity level. The remaining five measures are classified under the activity level.</p>
<p><xref ref-type="fig" rid="fig2">Figure 2</xref> illustrates the relationships among the three domains&#x2014;&#x201C;setting,&#x201D; &#x201C;measurement,&#x201D; and &#x201C;stroke recovery phase&#x201D;&#x2014;using connections of varying widths, where the thickness of each connection reflects the number of shared elements between the domains.</p>
<fig position="float" id="fig2">
<label>Figure 2</label>
<caption>
<p>Sankey diagram of setting, measurement, and phase. BI, Barthel Index; CG, control group; FAC, Functional Ambulation Categories; FMA, Fugl-Meyer-Assessment; FMA-UL, Fugl-Meyer-Assessment upper extremity; FMA LL, Fugl-Meyer-Assessment lower extremity; IG, intervention group; LAMS, Los Angeles Motor Scale; mBI, Modified Barthel Index; mRS, modified Rankin Scale; NIHSS, National Institute Stroke Scale; OCSPC, Oxfordshire Community Stroke Project Classification.</p>
</caption>
<graphic xlink:href="fneur-16-1631275-g002.tif">
<alt-text content-type="machine-generated">Sankey diagram illustrating the relationship between settings, measures, and stroke recovery phases using colored flows. The settings are clinic, rehabilitation, and non-clinical. Measures include NIHSS, mRS, FMA, among others. Stroke recovery phases are noted as acute, chronic, and subacute, among others. The flows indicate connections between these categories.</alt-text>
</graphic>
</fig>
</sec>
<sec id="sec15">
<label>3.3</label>
<title>Cut-off scores</title>
<p>Study protocols provided different cut-off scores to assess severe stroke (<xref ref-type="fig" rid="fig3">Figures 3</xref>&#x2013;<xref ref-type="fig" rid="fig5">5</xref>). For the NIHSS, the range for severe stroke was &#x003E;5 and &#x003C;20 (<xref ref-type="bibr" rid="ref21">21</xref>) to 21&#x2013;24 (<xref ref-type="bibr" rid="ref22">22</xref>, <xref ref-type="bibr" rid="ref23">23</xref>). For the FMA the cut-off score applied was &#x003C; 25 (<xref ref-type="bibr" rid="ref24">24</xref>) and &#x003C;50 (<xref ref-type="bibr" rid="ref17">17</xref>). For the FMA-UL, the cut-off score was &#x003C;30 (<xref ref-type="bibr" rid="ref25">25</xref>) or &#x2264; 21 (<xref ref-type="bibr" rid="ref26">26</xref>). For the BI, a cut-off score of &#x2264; 40 (<xref ref-type="bibr" rid="ref27">27</xref>) or &#x003C;30 (<xref ref-type="bibr" rid="ref28">28</xref>) was used to assess severe stroke. In 11 studies (<xref ref-type="bibr" rid="ref16">16</xref>, <xref ref-type="bibr" rid="ref20">20</xref>, <xref ref-type="bibr" rid="ref29 ref30 ref31 ref32 ref33 ref34 ref35 ref36 ref37">29&#x2013;37</xref>), the cut-off scores for the evaluation of the severity of stroke were not specified.</p>
<fig position="float" id="fig3">
<label>Figure 3</label>
<caption>
<p>Measurements assessing severe stroke used in clinical settings; inner ring: stroke recovery phase; middle ring: measurements; outer ring: cut-off scores. BI, Barthel Index; FAC, Functional Ambulation Categories; FMA, Fugl-Meyer-Assessment; FMA LL, Fugl-Meyer-Assessments lower limb; FMA-UL, Fugl-Meyer-Assessment upper limb; LAMS, Los Angeles Motor Scale; mBI, modified Barthel Index; mRS, modified Rankin Scale; NIHSS, National Institute Stroke Scale; n.n., not named.</p>
</caption>
<graphic xlink:href="fneur-16-1631275-g003.tif">
<alt-text content-type="machine-generated">Circular chart with four colored sections: green, blue, purple, and orange representing different medical stages: early subacute, late subacute, chronic, and acute, respectively. Each section contains multiple nested segments labeled with medical acronyms such as NIHSS, mRS, OSCPS, FMA, and numerical values like 21-24, &#x003E;16, and &#x003C;50.</alt-text>
</graphic>
</fig>
<fig position="float" id="fig4">
<label>Figure 4</label>
<caption>
<p>Measurements assessing severe stroke used in rehabilitation settings; inner ring: stroke recovery phase; middle ring: measurements; outer ring: cut-off scores. BI, Barthel Index; FAC, Functional Ambulation Categories; FMA, Fugl-Meyer-Assessment; FMA LL, Fugl-Meyer-Assessments lower limb; FMA-UL, Fugl-Meyer-Assessment upper limb; LAMS, Los Angeles Motor Scale; mBI, modified Barthel Index; mRS, modified Rankin Scale; NIHSS, National Institute Stroke Scale; n.n., not named.</p>
</caption>
<graphic xlink:href="fneur-16-1631275-g004.tif">
<alt-text content-type="machine-generated">A circular diagram with concentric segments labeled with medical scales: NIHSS, BI, FMA-UL, mRS, FAC, and FMA-LL. Each segment represents a different time phase: acute, early subacute, late subacute, and chronic. Numerical values are included, such as &#x201C;&#x003E;6&#x201D;, &#x201C;&#x003E;30&#x201D;, and &#x201C;0-28&#x201D;, indicating scores or measurements relevant to these phases. Different colors distinguish each segment and phase.</alt-text>
</graphic>
</fig>
<fig position="float" id="fig5">
<label>Figure 5</label>
<caption>
<p>Measurements assessing severe stroke used in not clinical/rehabilitation settings; inner ring: stroke recovery phase; middle ring: measurements; outer ring: cut-off scores. BI, Barthel Index; FAC, Functional Ambulation Categories; FMA, Fugl-Meyer-Assessment; FMA LL, Fugl-Meyer-Assessments lower limb; FMA-UL, Fugl-Meyer-Assessment upper limb; LAMS, Los Angeles Motor Scale; mBI, modified Barthel Index; mRS, modified Rankin Scale; NIHSS, National Institute Stroke Scale; n.n., not named.</p>
</caption>
<graphic xlink:href="fneur-16-1631275-g005.tif">
<alt-text content-type="machine-generated">Circular chart illustrating stages and assessments of stroke recovery. Segments are color-coded: green for acute, orange for late subacute, blue for early subacute, and purple for chronic. Labels include NIHSS, BI, FMA, FAC, mRS, with numerical values and abbreviations indicating assessment scores.</alt-text>
</graphic>
</fig>
</sec>
</sec>
<sec sec-type="discussion" id="sec16">
<label>4</label>
<title>Discussion</title>
<p>Clinical manifestation of stroke varies depending on factors like etiology, localization, and stroke severity, with initial stroke severity known to be a crucial predictor of outcomes (<xref ref-type="bibr" rid="ref38">38</xref>). Scales and measurements help to quantify the severity of stroke symptoms, aiding in treatment decisions. The focus of this scoping review was to give an overview of the measurements, and the cut-off scores used in clinical research to classify stroke severity.</p>
<p>Clinical symptoms undergo considerable changes over time. Guidelines consider these diverse areas of post-stroke disability and their associated symptoms beyond the acute phase of the disease. Stroke recovery includes the examination of level of consciousness, overall neurological impairment, motor function, balance, cognition, speech and language, Activities of Daily Living (ADL), depression, family functioning, and quality of life (<xref ref-type="bibr" rid="ref39">39</xref>). For this study, research protocols focus on different outcomes, which require different methods and measures suitable for the individual research aim. On the one hand, the multitude of measures presented in this current review is not surprising; instead, they reflect the many different post-stroke symptoms and aims of stroke research. On the other hand, various measures to assess stroke lead to limitations in stroke research as the non-uniform use limits the ability to assemble treatment evidence across trials (<xref ref-type="bibr" rid="ref40">40</xref>, <xref ref-type="bibr" rid="ref41">41</xref>). This review counted 11 measurements, underlining the lack of standardization. According to the roundtable, other outcome measures aligned with the trial&#x2019;s purpose and target intervention can be added. The recommendation applies across all stages, from the hyperacute to the early and late subacute to the chronic phase. For the studies included in this review, it can be stated that this recommendation was not followed in 21 out of 35 studies.</p>
<p>With that in mind, it must be additionally mentioned that completely different constructs are assessed when using the FAC, the FMA-UL or the ARAT, for example. It should be critically questioned whether it is sufficient to determine the severity of a stroke solely based on walking or upper limb function. For the sake of completeness, it must also be said that the NIHSS does not provide information on activities of daily living like walking or transfers, which are crucial factors for patients&#x2019; independence and thus for discharge. The results of this scoping review seem to reflect the lack of a single measure capturing all ICF levels. The second part of the current research question referred to quantifying severe stroke. Results showed that the cut-off scores used for identical measurements varied in the included studies. This is especially notable for the NIHSS and the FMA. Among the studies that reported cut-offs for the NIHSS, seven different ones were found. Buvarp et al. (<xref ref-type="bibr" rid="ref42">42</xref>) indicated a cut-off for severe stroke at &#x003E;6 points. Kamal et al. (<xref ref-type="bibr" rid="ref43">43</xref>) at &#x003E;9 points, Ouyang et al. (<xref ref-type="bibr" rid="ref44">44</xref>) at &#x003E;15, Smith et al. (<xref ref-type="bibr" rid="ref45">45</xref>) at &#x003E;16, Liu et al. (<xref ref-type="bibr" rid="ref46">46</xref>) at &#x003E;20, Frange (<xref ref-type="bibr" rid="ref21">21</xref>) &#x003E;5 and &#x003E;20 and Radford et al. (<xref ref-type="bibr" rid="ref22">22</xref>) between 21 and 24. Results with a value of 9 out of 42 points can hardly be comparable with one of 20. Similarly, different cut-off values can be found in the results of the FMA with cut-offs less than 25 or less than 50. The authors of the studies included refer to various sources. Without the authors giving more detailed reasons for the cut-off scores used, it can be assumed that the scores are adapted to the respective population and setting. A cut-off score could be comprehensible and appropriate for individual study, but it must be considered, as it limits quantitative synthesis.</p>
<sec id="sec17">
<label>4.1</label>
<title>Strengths and limitations</title>
<p>This is the first study about the realization of stroke measures focusing on assessing severe stroke and the used cut-off scores. One strength of this review is the comprehensive search strategy specific to non-medical therapeutic interventions in stroke rehabilitation. Furthermore, the research team provides a diverse educational/professional background in treating severe stroke patients.</p>
<p>A reason for the limited number of search results was the inclusion of CCT and RCT study types. Because there is extensive research in the neurorehabilitation of stroke, the quality of these studies also provided the opportunity to include studies that may be of interest for guideline recommendations.</p>
<p>This review&#x2019;s wide range of measures reflects the diversity of existing tools for assessing stroke severity. These results highlight the variety of measures used in research and those used in clinical practice to evaluate severe stroke.</p>
</sec>
</sec>
<sec sec-type="conclusions" id="sec18">
<label>5</label>
<title>Conclusion</title>
<p>Using different instruments and cut-off scores to assess stroke severity, the measurements&#x2019; informative value is limited. It remains unclear what functional abilities the affected person has, as the measurements are based on non-standardized constructs. The categorization and standardization of stroke severity could facilitate communication between healthcare professionals, health insurance companies, and healthcare institutions. This is the case if there is a mutual understanding of stroke severity across all sectors. The use of the NIHSS as a basic instrument, as recommended by the Roundtable, and an instrument addressing the ICF level could reflect the actual situation of patients. Further research is required into obligatory, cross-setting cut-off scores.</p>
</sec>
</body>
<back>
<sec sec-type="author-contributions" id="sec19">
<title>Author contributions</title>
<p>KR: Conceptualization, Data curation, Formal analysis, Methodology, Project administration, Resources, Validation, Visualization, Writing &#x2013; original draft, Writing &#x2013; review &#x0026; editing. HB: Conceptualization, Data curation, Formal analysis, Methodology, Project administration, Resources, Validation, Writing &#x2013; original draft, Writing &#x2013; review &#x0026; editing. NS: Conceptualization, Data curation, Formal analysis, Funding acquisition, Methodology, Project administration, Validation, Writing &#x2013; original draft, Writing &#x2013; review &#x0026; editing.</p>
</sec>
<sec sec-type="funding-information" id="sec20">
<title>Funding</title>
<p>The author(s) declare that financial support was received for the research and/or publication of this article. The open access publication was facilitated by the support of the Martin-Luther-University of Halle-Wittenberg Germany.</p>
</sec>
<sec sec-type="COI-statement" id="sec21">
<title>Conflict of interest</title>
<p>The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.</p>
</sec>
<sec sec-type="ai-statement" id="sec22">
<title>Generative AI statement</title>
<p>The authors declare that no Gen AI was used in the creation of this manuscript.</p>
</sec>
<sec sec-type="disclaimer" id="sec23">
<title>Publisher&#x2019;s note</title>
<p>All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.</p>
</sec>
<sec sec-type="supplementary-material" id="sec24">
<title>Supplementary material</title>
<p>The Supplementary material for this article can be found online at: <ext-link xlink:href="https://www.frontiersin.org/articles/10.3389/fneur.2025.1631275/full#supplementary-material" ext-link-type="uri">https://www.frontiersin.org/articles/10.3389/fneur.2025.1631275/full#supplementary-material</ext-link></p>
<supplementary-material xlink:href="Table_1.docx" id="SM1" mimetype="application/vnd.openxmlformats-officedocument.wordprocessingml.document" xmlns:xlink="http://www.w3.org/1999/xlink"/>
</sec>
<fn-group>
<fn id="fn0001"><p><sup>1</sup>OSF, register number: 10.17605/OSF.IO/WYR5H, <ext-link xlink:href="https://osf.io/wyr5h" ext-link-type="uri">https://osf.io/wyr5h</ext-link></p></fn>
</fn-group>
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