A Systematic Review of Female Participation in Randomized Controlled Trials of Post-Stroke Upper Extremity Rehabilitation in Low- to Middle-Income Countries and High-Income Countries and Regions.

INTRODUCTION: Female participation is lower than males in both acute stroke and stroke rehabilitation trials. However, less is known about how female participation differs across countries and regions. This study aimed to assess the percentage of female participants in randomized controlled trials (RCTs) of post-stroke rehabilitation of upper extremity (UE) motor disorders in low-middle-income (LMICs) and high-income countries (HICs) as well as different high-income world regions. METHODS: CINAHL, Embase, PubMed, Scopus, and Web of Science were searched from 1960 to April 1, 2021. Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English; (2) ≥50% of participants were diagnosed with stroke; 3) included adults ≥18 years old; and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. Countries were divided into HICs and LMICs based on their growth national incomes. The HICs were further divided into the three high-income regions of North America, Europe, and Asia and Oceania. Data analysis was performed using SPSS and RStudio v.4.3.1. RESULTS: A total of 1,276 RCTs met inclusion criteria. Of them, 298 RCTs were in LMICs and 978 were in HICs. The percentage of female participants was significantly higher in HICs (39.5%) than LMICs (36.9%). Comparing high-income regions, there was a significant difference in the overall female percentages in favor of RCTs in Europe compared to LMICs but not North America or Asia and Oceania. There was no significant change in the percentage of female participants in all countries and regions over the last 2 decades, with no differences in trends between the groups. CONCLUSIONS: Sufficient female representation in clinical trials is required for the generalizability of results. Despite differences in overall percentage of female participation between countries and regions, females have been underrepresented in both HICs and LMICs with no considerable change over 2 decades.

Female Enrollment in Rehabilitation Trials: A Systematic Review of Reporting Sex and Female Participation in Randomized Controlled Trials of Poststroke Upper Extremity Rehabilitation Over 50 Years.

OBJECTIVE: To systematically assess the reporting of sex and the percentage of female participants in randomized controlled trials (RCTs) examining interventions for the post-stroke rehabilitation of upper extremity (UE) motor disorders. DATA SOURCES: CINAHL, Embase, PubMed, Scopus and Web of Science were searched from 1960 to April 1, 2021. Additional articles were identified using the Evidence-Based Review of Stroke Rehabilitation. STUDY SELECTION: Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English, (2) ≥50% of participants were diagnosed and affected by stroke, (3) included adults ≥18 years old, and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. DATA EXTRACTION: Two investigators independently screened the title and abstracts, and duplicates were removed. A full-text review was done for studies that met all inclusion criteria. Data were extracted using a custom data extraction template in Covidence and were transferred to online Excel (V16) for data management. Study characteristics and extracted variables were summarized using standard descriptive statistics. Data analyses were performed using SPSS (V29.0). DATA SYNTHESIS: A total of 1276 RCTs met inclusion criteria, and of these, 5.2% did not report results on sex, accounting for 5.6% of participants. Women have been underrepresented in stroke RCTs, accounting for 38.8% of participants. Female participation was greater in the acute poststroke phase than in the chronic and subacute phases. Over almost 5 decades, there has been a small decrease in the proportion of female participants in these trials. CONCLUSIONS: Evidence-based medicine for the treatment and prevention of stroke is guided by results from RCTs. Generalizability depends on sufficient representation in clinical trials. Stakeholders, such as funders and journal editors, play a key role in encouraging researchers to enroll enough of both sexes and to report the presence or absence of sex differences in RCTs.

Updated Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury: Mental Health Recommendations.

OBJECTIVE: Objective: After sustaining a moderate to severe traumatic brain injury (MSTBI), individuals often experience comorbid mental health conditions that can impair the rehabilitation and recovery process. The objective of this initiative was to update recommendations on the assessment and management of mental health conditions for the Canadian Clinical Practice Guideline for the Rehabilitation of Adults with MSTBI (CAN-TBI 2023). OBJECTIVE: Design: A systematic search was conducted by the Evidence-Based Review of Moderate to Severe Acquired Brain Injury to identify new and relevant articles. Expert Panel reviewed and discussed the new and existing evidence, evaluated its quality, and added, removed, or modified recommendations and tools as needed. A consensus process was followed to achieve agreement on recommendations. OBJECTIVE: Results: CAN-TBI 2023 includes 20 recommendations regarding best practices for the assessment and management of mental health conditions post-MSTBI. About 17 recommendations were updated, 1 new recommendation was formed, and 2 recommendations remained unchanged. The Guideline emphasizes the importance of screening and assessment of mental health conditions throughout the rehabilitation continuum. The Expert Panel recommended incorporating multimodal treatments that include pharmacological and nonpharmacological approaches to manage mental health concerns. OBJECTIVE: Conclusion: The CAN-TBI 2023 recommendations for the assessment and management of mental health conditions should be used to inform clinical practice. Additional high-quality research in this area is needed, as 13 recommendations are based on level C evidence, 4 on level B evidence, and 3 on level A evidence.

Updated Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury: Behavioral Recommendations.

OBJECTIVE: Behavioral changes following moderate to severe traumatic brain injury (MSTBI) are common and can include agitation or aggression, reduced arousal or apathy, and inappropriate sexual behavior. These changes can negatively affect recovery, function, and quality of life. Pharmacological and nonpharmacological interventions are often used to address these challenges; however, there is limited evidence regarding the effectiveness of these treatments. This article will summarize the updated recommendations for the assessment and management of behavioral changes in adults after MSTBI. DESIGN: A systematic search was conducted by the evidence-based review of moderate to severe acquired brain injury to identify new and relevant articles. Expert panels reviewed and discussed the new and existing evidence, evaluated its quality, and added, removed, or modified recommendations and tools as needed. A consensus process was followed to achieve agreement on recommendations. RESULTS: The 2023 Canadian Clinical Practice Guideline for the Rehabilitation of Adults with Moderate to Severe Traumatic Brain Injury (CAN-TBI 2023) includes 21 recommendations regarding best practices for the assessment and management of behavioral disorders post-MSTBI. Fifteen recommendations remained unchanged, and 6 recommendations were updated. Eight recommendations are based on level B evidence and 13 on level C evidence. There are no recommendations based on level A evidence. The guideline also includes a step-by-step algorithm for clinicians to follow outlining an approach to the assessment and management of agitation and aggression. CONCLUSION: CAN-TBI 2023 will assist clinicians in the assessment and safe and effective management of behavioral changes post-MSTBI. The guideline is informed by a growing scientific database although there is a need for additional high-quality research to better guide the assessment and management of this complex patient population.

Experiences and Challenges Updating a Living Evidence-Based Review of Randomized Controlled Trials on Mental Health and Behavioral Disorders in Individuals With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To describe experiences and challenges when updating a living evidence-based review database of randomized controlled trials (RCTs) on mental health and behavioral disorders in moderate to severe traumatic brain injury (MSTBI). METHOD: This commentary derives from our experience developing an extensive database of RCTs on MSTBI that has been conceptualized as a living evidence-based review. Our working group focused on mental health and behavior RCTs and reflected upon their experiences and challenges using the living systematic approach. We discuss challenges associated with metrics of study quality, injury etiology and severity, time post-injury, country of origin, and variability in outcome measures. RESULTS: RCTs were conducted almost solely in high income countries, with smaller sample sizes, and most conducted in the chronic phase post-TBI. Issues related to lack of transparency, unclear and incomplete reporting of injury severity, etiology, and time post-injury remain a concern and can lead to challenges associated with interpretation of results, validity, and reliability of the data. There was significant heterogeneity regarding the use of outcome measures and constructs, underscoring the need for standardization. CONCLUSION: Lack of standardization and incomplete reporting of injury characteristics makes it difficult to compare data between RCTs of MSTBI, perform meta-analyses, and generate evidence-based clinical recommendations.

Lessons Learned From Moving to Living Guidelines-The Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate-to-Severe TBI.

OBJECTIVE: It is often challenging for providers to remain up to date with best practices gleaned from clinical research. Consequently, patients may receive inappropriate, suboptimal, and costly care. Living clinical practice guidelines (CPGs) maintain the methodological rigor of traditional CPGs but are continuously updated in response to new research findings, changes in clinical practice, and emerging evidence. The objective of this initiative was to discuss the lessons learned from the transformation of the Canadian Clinical Practice Guideline for the Rehabilitation of Adults with Traumatic Brain Injury (CAN-TBI) from a traditional guideline update model to a living guideline model. DESIGN: The CAN-TBI Guideline provides evidence-based rehabilitative care recommendations for individuals who have sustained a TBI. The Guideline is divided into 2 sections: Section I, which provides guidance on the components of the optimal TBI rehabilitation system, and Section II, which focuses on the assessment and rehabilitation of brain injury sequelae. A comprehensive outline of the living guideline process is presented. RESULTS: The CAN-TBI living guideline process has yielded 351 recommendations organized within 21 domains. Currently, 30 recommendations are supported by level A evidence, 81 recommendations are supported by level B evidence, and 240 consensus-based recommendations (level C evidence) comprise 68% of the CAN-TBI Guideline. CONCLUSION: Given the increasing volume of research published on moderate-to-severe TBI rehabilitation, the CAN-TBI living guideline process allows for real-time integration of emerging evidence in response to the fastest-growing topics, ensuring that practitioners have access to the most current and relevant recommendations.

Evidence-Based Review of Randomized Controlled Trials of Interventions for Mental Health Management Post-Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To present an evidence-based review of randomized controlled trials (RCTs) evaluating interventions for mental health post-moderate to severe traumatic brain injury (post-MSTBI), as part of an extensive database that has been conceptualized as a living systematic review. METHODS: Systematic searches were conducted for RCTs published in the English language in MEDLINE, PubMed, Scopus, CINAHL, EMBASE, and PsycINFO, up to and including December 2022, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The methodological quality of RCTs was assessed using the Physiotherapy Evidence Database scale, and the level of evidence was assigned using a modified Sackett scale. RESULTS: Eighty-seven RCTs examining mental health interventions and outcome measures post-MSTBI were included. These studies collectively enrolled 6471 participants. A total of 41 RCTs (47.1%) were conducted in the United States and 56 studies (64.4%) were published after 2010. A total of 62 RCTs (71.3%) examined nonpharmacological interventions and 25 RCTs (28.7%) examined pharmacological interventions. Effective pharmacological treatments included desipramine and cerebrolysin; methylphenidate and rivastigmine showed conflicting evidence. Cognitive behavioral therapy (CBT) was found to be effective for hopelessness, stress, and anxiety, compared to usual care; however, it may be as effective as supportive psychotherapy for depression. CBT combined with motivational interviewing may be as effective as CBT combined with nondirective counseling for depression, stress, and anxiety. Acceptance and commitment therapy was effective for anxiety, stress, and depression. Tai Chi, dance, and walking appeared to be effective for depression and stress, while other nonpharmacological treatments such as peer mentoring showed limited effectiveness. CONCLUSION: This evidence-based review provides a comprehensive overview of the research landscape of RCTs addressing mental health post-MSTBI. The findings from these RCTs may be valuable for health care professionals, researchers, and policymakers involved in the field of mental health and neurorehabilitation.

Evidence-Based Review of Randomized Controlled Trials of Interventions for the Management of Behavioral Issues in Individuals With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To present an evidence-based review of randomized controlled trials (RCTs) evaluating interventions for the management of behavioral issues post moderate to severe traumatic brain injury (MSTBI), as part of an extensive database that has been conceptualized as a living systematic review. METHODS: Systematic searches were conducted in MEDLINE, PubMed, Scopus, CINAHL, EMBASE and PsycINFO, up to and including December 2022, for articles published in the English language, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of RCT was assessed using the Physiotherapy Evidence Database (PEDro) scale, and level of evidence was assigned using a modified Sackett scale. RESULTS: Forty-six RCTs examining interventions and outcome measures related to behavioral issues post-MSTBI were included. These studies collectively enrolled 3,267 participants. The majority of RCTs were conducted in the United States (n = 27; 58.7%) and 28 (60.9%) were conducted after 2010. Of these, 27 RCTs examined non-pharmacological interventions and 19 examined pharmacological interventions. Effective pharmacological treatments included amantadine and dexmedetomidine. Effective non-pharmacological interventions included sensory stimulation in the acute phase, anger self-management programs, peer mentoring, problem-solving, and emotional regulation. Psychotherapy showed conflicting evidence. CONCLUSION: This evidence-based review provides a comprehensive overview of the research landscape of RCTs addressing behavior post-MSTBI. The findings from these RCTs may be valuable for health care professionals, researchers, and policymakers involved in the field of TBI and behavior.

Cognitive behavioral therapy for managing depressive and anxiety symptoms after brain injury: a meta-analysis.

BACKGROUND: Individuals with traumatic brain injury (TBI) are at increased risk of depression and anxiety, leading to impaired recovery. While cognitive-behavioral therapy (CBT) addresses anxiety and depression maintenance factors, its efficacy among those with TBI has not been clearly demonstrated. This review aims to bridge this gap in the literature. METHODS: Several databases, including Medline, PsycInfo and EMBASE, were used to identify studies published between 1990 and 2021. Studies were included if: (1) trials were randomized controlled trials (RCT) involving CBT-based intervention targeting anxiety and/or depression; (2) participants experienced brain injury at least 3-months previous; (3) participants were ≥18 years old. An SMD ± SE, 95% CI and heterogeneity were calculated for each outcome. RESULTS: Thirteen RCTs were included in this meta-analysis. The pooled-sample analyses suggest that CBT interventions had small immediate post-treatment effects on reducing depression (SMD ± SE: 0.391 ± 0.126, p < 0.005) and anxiety (SMD ± SE: 0.247 ± 0.081, p < 0.005). Effects were sustained at a 3-months follow-up for depression. A larger effect for CBT was seen when compared with supportive therapy than control. Another sub-analysis found that individualized CBT resulted in a slightly higher effect compared to group-based CBT. CONCLUSION: This meta-analysis provides substantial evidence for CBT in managing anxiety and depression post-TBI.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury: Methods, Overview, and Principles.

INTRODUCTION: Moderate to severe traumatic brain injury (TBI) results in complex cognitive sequelae. Despite hundreds of clinical trials in cognitive rehabilitation, the translation of these findings into clinical practice remains a challenge. Clinical practice guidelines are one solution. The objective of this initiative was to reconvene the international group of cognitive researchers and clinicians (known as INCOG) to develop INCOG 2.0: Guidelines for Cognitive Rehabilitation Following TBI. METHODS: The guidelines adaptation and development cycle was used to update the recommendations and derive new ones. The team met virtually and reviewed the literature published since the original INCOG (2014) to update the recommendations and decision algorithms. The team then prioritized the recommendations for implementation and modified the audit tool accordingly to allow for the evaluation of adherence to best practices. RESULTS: In total, the INCOG update contains 80 recommendations (25 level A, 15 level B, and 40 level C) of which 27 are new. Recommendations developed for posttraumatic amnesia, attention, memory, executive function and cognitive-communication are outlined in other articles, whereas this article focuses on the overarching principles of care for which there are 38 recommendations pertaining to: assessment (10 recommendations), principles of cognitive rehabilitation (6 recommendations), medications to enhance cognition (10 recommendations), teleassessment (5 recommendations), and telerehabilitation intervention (7 recommendations). One recommendation was supported by level A evidence, 7 by level B evidence, and all remaining recommendations were level C evidence. New to INCOG are recommendations for telehealth-delivered cognitive assessment and rehabilitation. Evidence-based clinical algorithms and audit tools for evaluating the state of current practice are also provided. CONCLUSIONS: Evidence-based cognitive rehabilitation guided by these recommendations should be offered to individuals with TBI. Despite the advancements in TBI rehabilitation research, further high-quality studies are needed to better understand the role of cognitive rehabilitation in improving patient outcomes after TBI.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part IV: Cognitive-Communication and Social Cognition Disorders.

INTRODUCTION: Moderate to severe traumatic brain injury causes significant cognitive impairments, including impairments in social cognition, the ability to recognize others' emotions, and infer others' thoughts. These cognitive impairments can have profound negative effects on communication functions, resulting in a cognitive-communication disorder. Cognitive-communication disorders can significantly limit a person's ability to socialize, work, and study, and thus are critical targets for intervention. This article presents the updated INCOG 2.0 recommendations for management of cognitive-communication disorders. As social cognition is central to cognitive-communication disorders, this update includes interventions for social cognition. METHODS: An expert panel of clinicians/researchers reviewed evidence published since 2014 and developed updated recommendations for interventions for cognitive-communication and social cognition disorders, a decision-making algorithm tool, and an audit tool for review of clinical practice. RESULTS: Since INCOG 2014, there has been significant growth in cognitive-communication interventions and emergence of social cognition rehabilitation research. INCOG 2.0 has 9 recommendations, including 5 updated INCOG 2014 recommendations, and 4 new recommendations addressing cultural competence training, group interventions, telerehabilitation, and management of social cognition disorders. Cognitive-communication disorders should be individualized, goal- and outcome-oriented, and appropriate to the context in which the person lives and incorporate social communication and communication partner training. Group therapy and telerehabilitation are recommended to improve social communication. Augmentative and alternative communication (AAC) should be offered to the person with severe communication disability and their communication partners should also be trained to interact using AAC. Social cognition should be assessed and treated, with a focus on personally relevant contexts and outcomes. CONCLUSIONS: The INCOG 2.0 recommendations reflect new evidence for treatment of cognitive-communication disorders, particularly social interactions, communication partner training, group treatments to improve social communication, and telehealth delivery. Evidence is emerging for the rehabilitation of social cognition; however, the impact on participation outcomes needs further research.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part III: Executive Functions.

INTRODUCTION: Moderate-to-severe traumatic brain injury (MS-TBI) causes debilitating and enduring impairments of executive functioning and self-awareness, which clinicians often find challenging to address. Here, we provide an update to the INCOG 2014 guidelines for the clinical management of these impairments. METHODS: An expert panel of clinicians/researchers (known as INCOG) reviewed evidence published from 2014 and developed updated recommendations for the management of executive functioning and self-awareness post-MS-TBI, as well as a decision-making algorithm, and an audit tool for review of clinical practice. RESULTS: A total of 8 recommendations are provided regarding executive functioning and self-awareness. Since INCOG 2014, 4 new recommendations were made and 4 were modified and updated from previous recommendations. Six recommendations are based on level A evidence, and 2 are based on level C. Recommendations retained from the previous guidelines and updated, where new evidence was available, focus on enhancement of self-awareness (eg, feedback to increase self-monitoring; training with video-feedback), meta-cognitive strategy instruction (eg, goal management training), enhancement of reasoning skills, and group-based treatments. New recommendations addressing music therapy, virtual therapy, telerehabilitation-delivered metacognitive strategies, and caution regarding other group-based telerehabilitation (due to a lack of evidence) have been made. CONCLUSIONS: Effective management of impairments in executive functioning can increase the success and well-being of individuals with MS-TBI in their day-to-day lives. These guidelines provide management recommendations based on the latest evidence, with support for their implementation, and encourage researchers to explore and validate additional factors such as predictors of treatment response.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part II: Attention and Information Processing Speed.

INTRODUCTION: Moderate to severe traumatic brain injury (MS-TBI) commonly causes disruption in aspects of attention due to its diffuse nature and injury to frontotemporal and midbrain reticular activating systems. Attentional impairments are a common focus of cognitive rehabilitation, and increased awareness of evidence is needed to facilitate informed clinical practice. METHODS: An expert panel of clinicians/researchers (known as INCOG) reviewed evidence published from 2014 and developed updated guidelines for the management of attention in adults, as well as a decision-making algorithm, and an audit tool for review of clinical practice. RESULTS: This update incorporated 27 studies and made 11 recommendations. Two new recommendations regarding transcranial stimulation and an herbal supplement were made. Five were updated from INCOG 2014 and 4 were unchanged. The team recommends screening for and addressing factors contributing to attentional problems, including hearing, vision, fatigue, sleep-wake disturbance, anxiety, depression, pain, substance use, and medication. Metacognitive strategy training focused on everyday activities is recommended for individuals with mild-moderate attentional impairments. Practice on de-contextualized computer-based attentional tasks is not recommended because of lack of evidence of generalization, but direct training on everyday tasks, including dual tasks or dealing with background noise, may lead to gains for performance of those tasks. Potential usefulness of environmental modifications is also discussed. There is insufficient evidence to support mindfulness-based meditation, periodic alerting, or noninvasive brain stimulation for alleviating attentional impairments. Of pharmacological interventions, methylphenidate is recommended to improve information processing speed. Amantadine may facilitate arousal in comatose or vegetative patients but does not enhance performance on attentional measures over the longer term. The antioxidant Chinese herbal supplement MLC901 (NeuroAiD IITM) may enhance selective attention in individuals with mild-moderate TBI. CONCLUSION: Evidence for interventions to improve attention after TBI is slowly growing. However, more controlled trials are needed, especially evaluating behavioral or nonpharmacological interventions for attention.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part I: Posttraumatic Amnesia.

INTRODUCTION: Posttraumatic amnesia (PTA) is a common occurrence following moderate to severe traumatic brain injury (TBI) and emergence from coma. It is characterized by confusion, disorientation, retrograde and anterograde amnesia, poor attention and frequently, agitation. Clinicians and family need guidelines to support management practices during this phase. METHODS: An international team of researchers and clinicians (known as INCOG) met to update the INCOG guidelines for assessment and management of PTA. Previous recommendations and audit criteria were updated on the basis of review of the literature from 2014. RESULTS: Six management recommendations were made: 1 based on level A evidence, 2 on level B, and 3 on level C evidence. Since the first version of INCOG (2014), 3 recommendations were added: the remainder were modified. INCOG 2022 recommends that individuals should be assessed daily for PTA, using a validated tool (Westmead PTA Scale), until PTA resolution. To date, no cognitive or pharmacological treatments are known to reduce PTA duration. Agitation and confusion may be minimized by a variety of environmental adaptations including maintaining a quiet, safe, and consistent environment. The use of neuroleptic medications and benzodiazepines for agitation should be minimized and their impact on agitation and cognition monitored using standardized tools. Physical therapy and standardized activities of daily living training using procedural and errorless learning principles can be effective, but delivery should be tailored to concurrent levels of cognition, agitation, and fatigue. CONCLUSIONS: Stronger recommendations regarding assessment of PTA duration and effectiveness of activities of daily living training have been made. Evidence regarding optimal pharmacological and nonpharmacological management of confusion and agitation during PTA remains limited, with further research needed. These guidelines aim to enhance evidence-based care and maximize consistency of PTA management.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part V: Memory.

INTRODUCTION: Memory impairments affecting encoding, acquisition, and retrieval of information after moderate-to-severe traumatic brain injury (TBI) have debilitating and enduring functional consequences. The interventional research reviewed primarily focused on mild to severe memory impairments in episodic and prospective memory. As memory is a common focus of cognitive rehabilitation, clinicians should understand and use the latest evidence. Therefore, the INCOG ("International Cognitive") 2014 clinical practice guidelines were updated. METHODS: An expert panel of clinicians/researchers reviewed evidence published since 2014 and developed updated recommendations for intervention for memory impairments post-TBI, a decision-making algorithm, and an audit tool for review of clinical practice. RESULTS: The interventional research approaches for episodic and prospective memory from 2014 are synthesized into 8 recommendations (6 updated and 2 new). Six recommendations are based on level A evidence and 2 on level B. In summary, they include the efficacy of choosing individual or multiple internal compensatory strategies, which can be delivered in a structured or individualized program. Of the external compensatory strategies, which should be the primary strategy for severe memory impairment, electronic reminder systems such as smartphone technology are preferred, with technological advances increasing their viability over traditional systems. Furthermore, microprompting personal digital assistant technology is recommended to cue completion of complex tasks. Memory strategies should be taught using instruction that considers the individual's functional and contextual needs while constraining errors. Memory rehabilitation programs can be delivered in an individualized or mixed format using group instruction. Computer cognitive training should be conducted with therapist guidance. Limited evidence exists to suggest that acetylcholinesterase inhibitors improve memory, so trials should include measures to assess impact. The use of transcranial direct current stimulation (tDCS) is not recommended for memory rehabilitation. CONCLUSION: These recommendations for memory rehabilitation post-TBI reflect the current evidence and highlight the limitations of group instruction with heterogeneous populations of TBI. Further research is needed on the role of medications and tDCS to enhance memory.

Network Meta-Analysis of Non-Conventional Therapies for Improving Upper Limb Motor Impairment Poststroke.

BACKGROUND: Network meta-analysis is a method that can estimate relative efficacy between treatments that may not have been compared directly within the literature. The purpose of this study is to present a network meta-analysis of non-conventional interventions to improve upper extremity motor impairment after stroke. METHODS: A literature search was conducted in 5 databases from their inception until April 1, 2021. Terms were used to narrow down articles related to stroke, the upper extremity, and interventional therapies. Randomized controlled trials written in English were eligible if; 50% poststroke patients; ≥18 years old; applied an intervention for the upper extremity, and/or used the Fugl-Meyer upper extremity scale as an outcome measure; the intervention had ≥3 randomized controlled trials with comparisons against a conventional care group; conventional care groups were dose matched for therapy time. A Bayesian network meta-analysis approach was taken to estimate mean difference (MD) and 95% CI. RESULTS: One hundred seventy-six randomized controlled trials containing 6781 participants examining 20 non-conventional interventions were identified for inclusion within the final model. Eight of the identified interventions proved significantly better than conventional care, with modified constraint induced movement therapy (MD, 6.7 [95% CI, 4.3-8.9]), high frequency repetitive transcranial magnetic stimulation (MD, 5.4 [95% CI, 1.9-8.9]), mental imagery (MD, 5.4 [95% CI, 1.8-8.9]), bilateral arm training (MD, 5.2 [95% CI, 2.2-8.1]), and intermittent theta-burst stimulation (MD, 5.1 [95% CI, 0.62-9.5]) occupying the top 5 spots according to the surface under the cumulative ranking curve. CONCLUSIONS: Overall, it would seem that modified constraint induced movement therapy has the greatest probability of being the most effective intervention, with high-frequency repetitive transcranial magnetic stimulation, mental imagery, and bilateral arm training all having similar probabilities of occupying the next spot in the rankings. We think this analysis can provide a guide for where future resources and clinical trials should be directed, and where a clinician may begin when considering alternative therapeutic interventions.

The CanPain SCI clinical practice guidelines for rehabilitation management of neuropathic pain after spinal cord injury: 2021 update.

STUDY DESIGN: Clinical practice guidelines. OBJECTIVES: The objective was to update the 2016 version of the Canadian clinical practice guidelines for the management of neuropathic pain in people with spinal cord injury (SCI). SETTING: The guidelines are relevant for inpatient, outpatient and community SCI rehabilitation settings in Canada. METHODS: The guidelines were updated in accordance with the Appraisal of Guidelines for Research and Evaluation II tool. A Steering Committee and Working Group reviewed the relevant evidence on neuropathic pain management (encompassing screening and diagnosis, treatment and models of care) after SCI. The quality of evidence was scored using Grading of Recommendations Assessment, Development and Evaluation (GRADE). A consensus process was followed to achieve agreement on recommendations and clinical considerations. RESULTS: The working group identified and reviewed 46 additional relevant articles published since the last version of the guidelines. The panel agreed on 3 new screening and diagnosis recommendations and 8 new treatment recommendations. Two key changes to these treatment recommendations included the introduction of general treatment principles and a new treatment recommendation classification system. No new recommendations to model of care were made. CONCLUSIONS: The CanPainSCI recommendations for the management of neuropathic pain after SCI should be used to inform practice.

Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial.

BACKGROUND: Individuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke. METHODS: An assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months. RESULTS: Thirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported. CONCLUSIONS: This study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016).

Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation.

BACKGROUND: The ability to walk is commonly reported as a top rehabilitation priority for individuals after a stroke. However, not all individuals with stroke are able to practice walking, especially those who require more assistance from their therapist to do so. Powered robotic exoskeletons are a new generation of robotic-assisted gait training devices, designed to assist lower extremity movement to allow repetitious overground walking practice. To date, minimal research has been conducted on the use of an exoskeleton for gait rehabilitation after stroke. The following research protocol aims to evaluate the efficacy and acceptability, and thus adoptability, of an exoskeleton-based gait rehabilitation program for individuals with stroke. METHODS: This research protocol describes a prospective, multi-center, mixed-methods study comprised of a randomized controlled trial and a nested qualitative study. Forty adults with subacute stroke will be recruited from three inpatient rehabilitation hospitals and randomized to receive either the exoskeleton-based gait rehabilitation program or usual physical therapy care. The primary outcome measure is the Functional Ambulation Category at post-intervention, and secondary outcomes include motor recovery, functional mobility, cognitive, and quality-of-life measures. Outcome data will be collected at baseline, post-intervention, and at 6 months. The qualitative component will explore the experience and acceptability of using a powered robotic exoskeleton for stroke rehabilitation from the point of view of individuals with stroke and physical therapists. Semi-structured interviews will be conducted with participants who receive the exoskeleton intervention, and with the therapists who provide the intervention. Qualitative data will be analyzed using interpretive description. DISCUSSION: This study will be the first mixed-methods study examining the adoptability of exoskeleton-based rehabilitation for individuals with stroke. It will provide valuable information regarding the efficacy of exoskeleton-based training for walking recovery and will shed light on how physical therapists and patients with stroke perceive the device. The findings will help guide the integration of robotic exoskeletons into clinical practice. TRIAL REGISTRATION: NCT02995265 (clinicaltrials.gov), Registered 16 December 2016.

Evaluating the effectiveness of aquatic therapy on mobility, balance, and level of functional independence in stroke rehabilitation: a systematic review and meta-analysis.

OBJECTIVE: To meta-analyze and systematically review the effectiveness of aquatic therapy in improving mobility, balance, and functional independence after stroke. DATA SOURCES: Articles published in Medline, Embase, CINAHL, PsycINFO, and Scopus up to 20 August 2019. STUDY SELECTION: Studies met the following inclusion criteria: (1) English, (2) adult stroke population, (3) randomized or non-randomized prospectively controlled trial (RCT or PCT, respectively) study design, (4) the experimental group received >1 session of aquatic therapy, and (5) included a clinical outcome measure of mobility, balance, or functional independence. DATA EXTRACTION: Participant characteristics, treatment protocols, between-group outcomes, point measures, and measures of variability were extracted. Methodological quality was assessed using Physiotherapy Evidence Database (PEDro) tool, and pooled mean differences (MD) ± standard error and 95% confidence intervals (CI) were calculated for Functional Reach Test (FRT), Timed Up and Go Test (TUG), gait speed, and Berg Balance Scale (BBS). DATA SYNTHESIS: Nineteen studies (17 RCTs and 2 PCTs) with a mean sample size of 36 participants and mean PEDro score of 5.6 (range 4-8) were included. Aquatic therapy demonstrated statistically significant improvements over land therapy on FRT (MD = 3.511 ± 1.597; 95% CI: 0.381-6.642; P = 0.028), TUG (MD = 2.229 ± 0.513; 95% CI: 1.224-3.234; P < 0.001), gait speed (MD = 0.049 ± 0.023; 95% CI: 0.005-0.094; P = 0.030), and BBS (MD = 2.252 ± 0.552; 95% CI: 1.171-3.334; P < 0.001). CONCLUSIONS: While the effect of aquatic therapy on mobility and balance is statistically significant compared to land-based therapy, the clinical significance is less clear, highly variable, and outcome measure dependent.