{"title":"Comparison of Upper Extremity Function and Daily Use in Individuals with and without Post Stroke Depression.","authors":"Samar Assadi Khalil, Grace J Kim, Debbie Rand","doi":"10.1177/15459683231215332","DOIUrl":"10.1177/15459683231215332","url":null,"abstract":"<p><strong>Background: </strong>Post-stroke depression (PSD) is a frequent psychiatric complication, however very few studies have investigated its relation to the affected upper extremity (UE) post-stroke. <i>Objective</i>. To compare the affected UE in terms of motor impairment, functional ability, and daily-use in individuals with and without PSD during the first 6 months post-stroke.</p><p><strong>Methods: </strong>This study analyzed data from a previous cohort; participants were assessed at rehabilitation admission (T1), 6 weeks (T2), and 6 months (T3) post-stroke. At each time point we compared between participants with and without PSD (Geriatric Depression Scale score ≥ 5). The Fugl-Meyer Motor Assessment assessed motor impairment, Action Research Arm Test assessed functional ability, and the Rating of Everyday Arm-Use in the Community and Home assessed daily-use. Independence in daily activities and cognition were also assessed.</p><p><strong>Results: </strong>A total of 116 participants were recruited, 38% had PSD at T1. No significant differences were found between groups at T1 and T2. However, significant differences (<i>z</i> = -5.23 to -2.66, <i>p</i> < .01) were found between groups for all UE measures at T3; participants with PSD had lower motor and functional ability and less daily hand-use than participants without PSD. At T3 participants with PSD were also less independent in daily-living.</p><p><strong>Conclusions: </strong>PSD is associated with greater UE motor, functional, and daily-use disability at 6 months post-stroke. Our findings underscore the negative impact of PSD on UE during the crucial transition period when individuals return home and integrate back into the community. Further research is needed to delineate the effect of change in PSD status on UE outcomes post stroke.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"99-108"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10874110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138815992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Felipe Balistieri Santinelli, Cintia Ramari, Marie Poncelet, Deborah Severijns, Daphne Kos, Massimiliano Pau, Alon Kalron, Pieter Meyns, Peter Feys
{"title":"Between-Day Reliability of the Gait Characteristics and Their Changes During the 6-Minute Walking Test in People With Multiple Sclerosis.","authors":"Felipe Balistieri Santinelli, Cintia Ramari, Marie Poncelet, Deborah Severijns, Daphne Kos, Massimiliano Pau, Alon Kalron, Pieter Meyns, Peter Feys","doi":"10.1177/15459683231222412","DOIUrl":"10.1177/15459683231222412","url":null,"abstract":"<p><strong>Background: </strong>Gait characteristics and their changes during the 6-minute walking test (6MWT) in people with multiple sclerosis (pwMS) have been described in the literature, which one may refer to as walking fatigability in the body function level of the International Classification of Functioning, Disability, and Health. However, whether these metrics are reliable is unknown.</p><p><strong>Objective: </strong>To investigate the between-day reliability of the gait characteristics and their changes in pwMS and healthy controls (HCs).</p><p><strong>Methods: </strong>Forty-nine pwMS (EDSS 4.82 ± 1.22 and 54.7 ± 9.36 years) and 23 HCs (50.6 ± 6.1 years) performed the 6MWT, as fast as possible but safely while wearing Inertial Measurement Units. Gait characteristics were measured in the pace, rhythm, variability, asymmetry, kinematics, coordination, and postural control domains and were obtained in intervals of 1 minute during the 6MWT. In addition, gait characteristics change in the last minute compared with the first minute were calculated for all gait variables using a fatigability index (ie, distance walking index). The intraclass correlation coefficient (ICC), Bland-Altman Plots, and Standard error of measurement were applied to investigate reliability.</p><p><strong>Results: </strong>Reliability of gait characteristics, minute-by-minute, and for their changes (ie, using the fatigability index) ranged from poor to excellent (pwMS: ICC 0.46-0.96; HC: ICC 0.09-0.97 and pwMS: ICC 0-0.72; HC: ICC 0-0.77, respectively).</p><p><strong>Conclusion: </strong>Besides coordination, at least 1 variable of each gait domain showed an ICC of moderate or good reliability for gait characteristics changes in both pwMS and HC. These metrics can be incorporated into future clinical trials and research on walking fatigability.<b>Clinical Trial Registration:</b> NCT05412043.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"75-86"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139478828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeanette Tamplin, Simon J Haines, Felicity A Baker, Tanara Vieira Sousa, Zara Thompson, Helen Crouch, Stephen Dunn, Victoria Tull, Adam P Vogel, Meg E Morris
{"title":"ParkinSong Online: Feasibility of Telehealth Delivery and Remote Data Collection for a Therapeutic Group Singing Study in Parkinson's.","authors":"Jeanette Tamplin, Simon J Haines, Felicity A Baker, Tanara Vieira Sousa, Zara Thompson, Helen Crouch, Stephen Dunn, Victoria Tull, Adam P Vogel, Meg E Morris","doi":"10.1177/15459683231219269","DOIUrl":"10.1177/15459683231219269","url":null,"abstract":"<p><strong>Background: </strong>Parkinson's disease can negatively affect vocal functioning and social wellbeing, particularly in the latter stages of disease progression. Face-to-face group singing interventions can improve communication and wellbeing outcomes, yet not all people can access in-person sessions. To help overcome barriers to participation, exploration of the feasibility and utility of online therapeutic singing programs is needed.</p><p><strong>Objectives: </strong>To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week ParkinSong Online intervention on speech and wellbeing for people with Parkinson's disease.</p><p><strong>Methods: </strong>A total of 28 participants with idiopathic Parkinson's disease were recruited to a single-arm feasibility study. Weekly 90-minute online sessions were co-facilitated by a music therapist and speech pathologist. Speech and wellbeing assessments were conducted pre and post intervention. Participant and facilitator surveys were administered after each session, with focus group interviews at the end of the program.</p><p><strong>Results: </strong>The recruitment rate was high (90%) with no attrition, adverse events, or safety issues. There was good intervention fidelity, attendance (average 89%), and positive participant experience. Feasibility was good, with technology reported as the main challenge (connecting and navigating Zoom). No improvements were seen in voice measures or wellbeing outcomes in this small trial. The online format used in this study did not provide the same benefits as in-person ParkinSong sessions.</p><p><strong>Conclusions: </strong>ParkinSong Online is feasible for recreational purposes and social engagement provided that people have adequate technological knowledge or support. The optimal online delivery format to achieve communication improvements in Parkinson's awaits confirmation.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"122-133"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10874111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139072472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rachel C Stockley, Marion F Walker, Margit Alt Murphy, Noor Azah Abd Aziz, Philemon Amooba, Leonid Churliov, Amanda Farrin, Natalie A Fini, Emma Ghaziani, Erin Godecke, Tania Gutierrez-Panchana, Jie Jia, Thoshenthri Kandasamy, Patrice Lindsay, John Solomon, Vincent Thijs, Tierney Tindall, Donna C Tippett, Caroline Watkins, Elizabeth Lynch
{"title":"Criteria and Indicators for Centers of Clinical Excellence in Stroke Recovery and Rehabilitation: A Global Consensus Facilitated by ISRRA.","authors":"Rachel C Stockley, Marion F Walker, Margit Alt Murphy, Noor Azah Abd Aziz, Philemon Amooba, Leonid Churliov, Amanda Farrin, Natalie A Fini, Emma Ghaziani, Erin Godecke, Tania Gutierrez-Panchana, Jie Jia, Thoshenthri Kandasamy, Patrice Lindsay, John Solomon, Vincent Thijs, Tierney Tindall, Donna C Tippett, Caroline Watkins, Elizabeth Lynch","doi":"10.1177/15459683231222026","DOIUrl":"10.1177/15459683231222026","url":null,"abstract":"<p><strong>Background: </strong>The aim of the International Stroke Recovery and Rehabilitation Alliance is to create a world where worldwide collaboration brings major breakthroughs for the millions of people living with stroke. A key pillar of this work is to define globally relevant criteria for centers that aspire to deliver excellent clinical rehabilitation and generate exceptional outcomes for patients.</p><p><strong>Objectives: </strong>This paper presents consensus work conducted with an international group of expert stroke recovery and rehabilitation researchers, clinicians, and people living with stroke to identify and define criteria and measurable indicators for Centers of Clinical Excellence (CoCE) in stroke recovery and rehabilitation. These were intentionally developed to be ambitious and internationally relevant, regardless of a country's development or income status, to drive global improvement in stroke services.</p><p><strong>Methods: </strong>Criteria and specific measurable indicators for CoCE were collaboratively developed by an international panel of stroke recovery and rehabilitation experts from 10 countries and consumer groups from 5 countries.</p><p><strong>Results: </strong>The criteria and associated indicators, ranked in order of importance, focused upon (i) optimal outcome, (ii) research culture, (iii) working collaboratively with people living with stroke, (iv) knowledge exchange, (v) leadership, (vi) education, and (vii) advocacy. Work is currently underway to user-test the criteria and indicators in 14 rehabilitation centers in 10 different countries.</p><p><strong>Conclusions: </strong>We anticipate that use of the criteria and indicators could support individual organizations to further develop their services and, more widely, provide a mechanism by which clinical excellence can be articulated and shared to generate global improvements in stroke care.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"87-98"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10874109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139428117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Taewon Kim, Keith R Lohse, Susan E Mackinnon, Benjamin A Philip
{"title":"Patient Outcomes After Peripheral Nerve Injury Depend on Bimanual Dexterity and Preserved Use of the Affected Hand.","authors":"Taewon Kim, Keith R Lohse, Susan E Mackinnon, Benjamin A Philip","doi":"10.1177/15459683241227222","DOIUrl":"10.1177/15459683241227222","url":null,"abstract":"<p><strong>Background: </strong>Little is known about how peripheral nerve injury affects human performance, behavior, and life. Hand use choices are important for rehabilitation after unilateral impairment, but rarely measured, and are not changed by the normal course of rehabilitation and daily life.</p><p><strong>Objective: </strong>To identify the relationship between hand use (L/R choices), motor performance, and patient-centered outcomes.</p><p><strong>Methods: </strong>Participants (n = 48) with unilateral peripheral nerve injury were assessed for hand use via Block Building Task, Motor Activity Log, and Edinburgh Handedness Inventory; dexterity (separately for each hand) via Nine-Hole Peg Test, Jebsen Taylor Hand Function Test, and a precision drawing task; patient-centered outcomes via surveys of disability, activity participation, and health-related quality of life; and injury-related factors including injury cause and affected nerve. Factor Analysis of Mixed Data was used to explore relationships between these variables. The data were analyzed under 2 approaches: comparing dominant hand (DH) versus non-dominant hand (NH), or affected versus unaffected hand.</p><p><strong>Results: </strong>The data were best explained by 5 dimensions. Good patient outcomes were associated with NH performance, DH performance (separately and secondarily to NH performance), and preserved function and use of the affected hand; whereas poor patient outcomes were associated with preserved but unused function of the affected hand.</p><p><strong>Conclusion: </strong>After unilateral peripheral nerve injury, hand function, hand usage, and patient life arise from a complex interaction of many factors. To optimize rehabilitation after unilateral impairment, new rehabilitation methods are needed to promote performance and use with the NH, as well as the injured hand.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"134-147"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10922924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139547872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Emily J Dalton, Rebecca Jamwal, Lia Augoustakis, Emma Hill, Hannah Johns, Vincent Thijs, Kathryn S Hayward
{"title":"Prevalence of Arm Weakness, Pre-Stroke Outcomes and Other Post-Stroke Impairments Using Routinely Collected Clinical Data on an Acute Stroke Unit.","authors":"Emily J Dalton, Rebecca Jamwal, Lia Augoustakis, Emma Hill, Hannah Johns, Vincent Thijs, Kathryn S Hayward","doi":"10.1177/15459683241229676","DOIUrl":"10.1177/15459683241229676","url":null,"abstract":"<p><strong>Introduction: </strong>The prevalence of upper limb motor weakness early post-stroke may be changing, which can have clinical and research implications. Our primary aim was to describe the prevalence of upper limb motor weakness early post-stroke, with a secondary aim to contextualize this prevalence by describing pre-stroke outcomes, other post-stroke impairments, functional activities, and discharge destination.</p><p><strong>Methods: </strong>This cross-sectional observational study extracted clinical data from confirmed stroke patients admitted to a metropolitan stroke unit over 15-months. The primary upper limb weakness measure was Shoulder Abduction and Finger Extension (SAFE) score. Demographics (eg, age), clinical characteristics (eg, stroke severity), pre-stroke outcomes (eg, clinical frailty), other post-stroke impairments (eg, command following), functional activities (eg, ambulation), and discharge destination were also extracted.</p><p><strong>Results: </strong>A total of 463 participants had a confirmed stroke and SAFE score. One-third of patients received ≥1 acute medical intervention(s). Nearly one-quarter of patients were classified as frail pre-stroke. Upper limb weakness (SAFE≤8) was present in 35% [95% CI: 30%-39%] at a median of 1-day post-stroke, with 22% presenting with mild-moderate weakness (SAFE5-8). The most common other impairments were upper limb coordination (46%), delayed recall (41%), and upper limb sensation (26%). After a median 3-day acute stroke stay, 52% of the sample were discharged home.</p><p><strong>Conclusion: </strong>Upper limb weakness was present in just over a third (35%) of the sample early post-stroke. Data on pre-stroke outcomes and the prevalence of other post-stroke impairments highlights the complexity and heterogeneity of stroke recovery. Further research is required to tease out meaningful recovery phenotypes and their implications.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"148-160"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10878009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139716795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Grant Rowe, Amira Allahham, Dale W Edgar, Brittany K Rurak, Mark W Fear, Fiona M Wood, Ann-Maree Vallence
{"title":"Functional Brain Changes Following Burn Injury: A Narrative Review.","authors":"Grant Rowe, Amira Allahham, Dale W Edgar, Brittany K Rurak, Mark W Fear, Fiona M Wood, Ann-Maree Vallence","doi":"10.1177/15459683231215331","DOIUrl":"10.1177/15459683231215331","url":null,"abstract":"<p><strong>Background: </strong>Burn injuries cause significant motor and sensory dysfunctions that can negatively impact burn survivors' quality of life. The underlying mechanisms of these burn-induced dysfunctions have primarily been associated with damage to the peripheral neural architecture, however, evidence points to a systemic influence of burn injury. Central nervous system (CNS) reorganizations due to inflammation, afferent dysfunction, and pain could contribute to persistent motor and sensory dysfunction in burn survivors. Recent evidence shows that the capacity for neuroplasticity is associated with self-reported functional recovery in burn survivors.</p><p><strong>Objective: </strong>This review first outlines motor and sensory dysfunctions following burn injury and critically examines recent literature investigating the mechanisms mediating CNS reorganization following burn injury. The review then provides recommendations for future research and interventions targeting the CNS such as non-invasive brain stimulation to improve functional recovery.</p><p><strong>Conclusions: </strong>Directing focus to the CNS following burn injury, alongside the development of non-invasive methods to induce functionally beneficial neuroplasticity in the CNS, could advance treatments and transform clinical practice to improve quality of life in burn survivors.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"62-72"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798013/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138479912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"International Stroke Recovery and Rehabilitation Roundtable Consensus Statements Are Driving Growth and Progress in Our Field.","authors":"Kathryn S Hayward, Gert Kwakkel, Julie Bernhardt","doi":"10.1177/15459683231223648","DOIUrl":"10.1177/15459683231223648","url":null,"abstract":"","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"3-6"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139072469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Coralie English, Dawn B Simpson, Sandra A Billinger, Leonid Churilov, Kirsten G Coupland, Avril Drummond, Annapoorna Kuppuswamy, Mansur A Kutlubaev, Anners Lerdal, Amreen Mahmood, G Lorimer Moseley, Quentin J Pittman, Ellyn A Riley, Brad A Sutherland, Connie Hy Wong, Dale Corbett, Gillian Mead
{"title":"A roadmap for research in post-stroke fatigue: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.","authors":"Coralie English, Dawn B Simpson, Sandra A Billinger, Leonid Churilov, Kirsten G Coupland, Avril Drummond, Annapoorna Kuppuswamy, Mansur A Kutlubaev, Anners Lerdal, Amreen Mahmood, G Lorimer Moseley, Quentin J Pittman, Ellyn A Riley, Brad A Sutherland, Connie Hy Wong, Dale Corbett, Gillian Mead","doi":"10.1177/15459683231209170","DOIUrl":"10.1177/15459683231209170","url":null,"abstract":"<p><strong>Rationale: </strong>Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities.</p><p><strong>Methods: </strong>We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed.</p><p><strong>Results: </strong>We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool.</p><p><strong>Conclusions: </strong>By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"7-18"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kathryn S Hayward, Emily J Dalton, Jessica Barth, Marian Brady, Leora R Cherney, Leonid Churilov, Andrew N Clarkson, Jesse Dawson, Sean P Dukelow, Peter Feys, Maree Hackett, Steve R Zeiler, Catherine E Lang
{"title":"Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.","authors":"Kathryn S Hayward, Emily J Dalton, Jessica Barth, Marian Brady, Leora R Cherney, Leonid Churilov, Andrew N Clarkson, Jesse Dawson, Sean P Dukelow, Peter Feys, Maree Hackett, Steve R Zeiler, Catherine E Lang","doi":"10.1177/15459683231209162","DOIUrl":"10.1177/15459683231209162","url":null,"abstract":"<p><p>Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. \"Identifying appropriate type of control\" was ranked easy to address and very important, \"variability in usual care\" was ranked hard to address and of low importance, and \"understanding the content of the control and how it differs from the experimental intervention\" was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders.</p>","PeriodicalId":94158,"journal":{"name":"Neurorehabilitation and neural repair","volume":" ","pages":"30-40"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}