Neighborhood socioeconomic disadvantage measures in rehabilitation clinical trials: Lessons learned in recruitment.

PURPOSE: The Area Deprivation Index (ADI) measures the relative disadvantage of an individual or social network using US Census indicators. Although a strong re-hospitalization predictor, ADI has not been routinely incorporated into rehabilitation research. The purposes of this paper are to examine the use of ADI related to study recruitment, association with carepartner psychosocial factors, and recruitment strategies to increase participant diversity. METHODS: Descriptive analysis of baseline data from a pilot stroke carepartner-integrated therapy trial. Participants were 32 carepartners (N = 32; 62.5 % female; mean age 57.8 ± 13.0 years) and stroke survivors (mean age (60.6 ± 14.2) residing in an urban setting. Measures included ADI, Bakas Caregiver Outcome Scale, Caregiver Strain Index, and Family Assessment Device. RESULTS: Most carepartners were Non-Hispanic White participants (61.3 %), part or fully employed (43 %), with >$50,000 (67.7 %) income, and all had some college education. Most stroke survivors were Non-Hispanic White participants (56.3 %) with some college (81.3 %). Median ADI state deciles were 3.0 (interquartile range 1.5-5, range 1-9), and mean national percentiles were 41.7 ± 23.5 with only 6.3 % of participants from the most disadvantaged neighborhoods. For the more disadvantaged half of the state deciles, the majority were Black or Asian participants. No ADI and carepartner factors were statistically related. CONCLUSIONS: The use of ADI data highlighted a recruitment gap in this stroke study, lacking the inclusivity of participants from disadvantaged neighborhoods and with lower education. Using social determinants of health indicators to identify underrepresented neighborhoods may inform recruitment methods to target marginalized populations and broaden the generalizability of clinical trials.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

OBJECTIVE: To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. DESIGN: Non-funded, pilot randomized controlled trial of intervention versus usual care. SETTING: International, multicentre, community-based. PARTICIPANTS: Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. INTERVENTIONS: Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. MAIN MEASURES: Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. RESULTS: In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). CONCLUSION: Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

The benefits of being a senior mentor: Cultivating resilience through the mentorship of health professions students.

Senior Mentor Programs (SMPs) pair community-dwelling older adults with health professions students to facilitate knowledge, improve communication skills, and promote positive attitudes regarding the aging process. Although evidence exists that SMPs meet these goals, the programs' psychosocial impact on the senior mentors remains unexplored. The current study assessed 101 mostly female (64.4%) senior mentors (M age = 77.6) pre- and postprogram. Although mentors had no change in the amount of perceived ageism experienced or expectation of experiencing ageism, their concern/anxiety over ageism significantly decreased from pre- (M = 21.58) to posttest (M = 20.19). Qualitative thematic analysis indicated meaningfulness of program and scheduling difficulties as prevalent themes. Mentors who reported less concern about ageism following the program were more likely to have experienced ageism in the year prior to the program and to attend religious services more often, another potential intergenerational contact. These results highlight possible benefits of mentor service for older adults.

Methodology of the Stroke Self-Management Rehabilitation Trial: an international, multisite pilot trial.

RATIONALE: Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support. However, reports of inadequate understanding of rehabilitation techniques are common. A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers' burden. AIMS: This article describes the methodology of the stroke self-management rehabilitation trial. The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial. DESIGN: Recruitment of a minimum of 20 survivors of stroke and their informal caregivers (where available) in each of the participating centers will occur across multiple international sites. After baseline assessments, participants will be randomly assigned to an intervention or standard care group. The intervention comprises a structured DVD observation and practice schedule over 8 weeks. All participants will complete follow-up assessments. STUDY OUTCOMES: The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores, changes in quality of life, general health, depression, and caregiver burden at 2 months postrandomization. A qualitative analysis of the effects of the intervention will also be undertaken. DISCUSSION: The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden.

Infusing motor learning research into neurorehabilitation practice: a historical perspective with case exemplar from the accelerated skill acquisition program.

UNLABELLED: : This special interest article provides a historical framework with a contemporary case example that traces the infusion of the science of motor learning into neurorehabilitation practice. The revolution in neuroscience provided the first evidence for learning-dependent neuroplasticity and presaged the role of motor learning as critical for restorative therapies after stroke. The scientific underpinnings of motor learning have continued to evolve from a dominance of cognitive or information processing perspectives to a blend with neural science and contemporary social-cognitive psychological science. Furthermore, advances in the science of behavior change have contributed insights into influences on sustainable and generalizable gains in motor skills and associated behaviors, including physical activity and other recovery-promoting habits. For neurorehabilitation, these insights have tremendous relevance for the therapist-patient interactions and relationships. We describe a principle-based intervention for neurorehabilitation termed the Accelerated Skill Acquisition Program that we developed. This approach emphasizes integration from a broad set of scientific lines of inquiry including the contemporary fields of motor learning, neuroscience, and the psychological science of behavior change. Three overlapping essential elements-skill acquisition, impairment mitigation, and motivational enhancements-are integrated. VIDEO ABSTRACT AVAILABLE: (See Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A71) for more insights from the authors.

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.

BACKGROUND: Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. METHODS/DESIGN: Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. DISCUSSION: ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. TRIAL REGISTRATION: www.ClinicalTrials.gov Identifier: NCT00871715

Remote Delivery of the Fugl-Meyer Assessment for the Upper Extremity: A Pilot Study to Assess Feasibility, Reliability, and Validity.

Objective: To develop a remote protocol for the upper extremity Fugl-Meyer Assessment (reFMA) and assess the reliability and validity with in-person delivery. Design: Feasibility testing. Setting: Remote/virtual and in-person in participants' homes. Participants: Three triads of therapists, stroke survivors, and carepartners (N=9) participated in Phases 1 and 2. Twelve different stroke survivors participated in Phase 3. Intervention: The FMA was administered and received remotely using the instructional protocol (Phases 1 and 2). Pilot testing with the delivery of the reFMA remotely and the FMA in-person occurred in Phase 3. Main Outcome Measures: Feedback for refinement and feasibility of obtaining the reFMA (including the System Usability Scale) and the FMA scores remotely and in-person to assess reliability and validity of the reFMA. Results: The reFMA was refined to incorporate feedback and suggestions from users. Interrater reliability between 2 therapists evaluating the FMA remotely was found to be poor with little agreement. For criterion validity, only 1 out of 12 (8.3%) total scores were in agreement between the in-person and remote assessments. Conclusion: Reliable and valid remote administration of the FMA is an important aspect of telerehabilitation for the upper extremity after stroke, but further research is needed to address current protocol limitations. This study provides preliminary support for the need for alternative strategies to improve appropriate implementation of the FMA remotely. Possible explanations for the poor reliability are explored and suggestions for improvement of the remote delivery of the FMA are provided.

Implementing Home-Based Clinical Research for Caregivers and Persons with Stroke: Lessons Learned.

Conducting research in the home environment presents challenges related to setting, study participants, methods, and researchers. Researchers should be aware of potential challenges to ensure rigor and improve planning for future studies. This paper describes difficulties experienced and lessons learned when conducting a two-group, randomized pilot study (n = 32) of a web-based intervention (Carepartner and Constraint-Induced Therapy [CARE-CITE]) designed to foster positive carepartner engagement in home-based activities to improve upper extremity function in persons with stroke. Challenges and issues included: 1) recruitment and referral, 2) data collection in the home setting, 3) participants' understanding of the rationale for adhering to constraint-induced movement therapy principles (wearing mitt on the less-affected limb), 4) tracking adherence of upper extremity practice time, 5) participant-driven goal setting, 6) potentially unsafe participant practice activities, 7) home visit safety, 8) encouraging versus controlling-using autonomy support, 9) participant needs beyond study scope, and 10) ethical safeguards for addressing depressive symptoms. Researchers can incorporate suggested strategies to support methodological rigor and facilitate interventions engaging carepartners in the rehabilitation process when planning for research in the home environment.

Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons with Stroke : Study Protocol for a Feasibility Study.

Background: Despite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this preliminary clinical trial is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility. Methods: This two-phased study will determine the feasibility of CARE-CITE-Gait, a novel intervention developed by our team that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-hour (home-based) visits for dyad collaborative goal setting. In Phase I, the usability and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In Phase II, feasibility (based on measures of recruitment, retention, and intervention adherence) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, evaluator blinded, quasi-experimental design with repeated measures (two baseline visits one week apart, post-test, and one-month follow-up) with 15 carepartner and stroke survivor dyads. Outcomes include psychosocial variables (strain, family conflict surrounding stroke recovery, autonomy support and life changes) collected from carepartners, and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors. Discussion: The findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process. Trial Registration: ClinicalTrials.gov, NCT05257928. Registered 25 February 2022, https://clinicaltrials.gov/ct2/show/NCT05257928.

Evaluation of a carepartner-integrated telehealth gait rehabilitation program for persons with stroke: study protocol for a feasibility study.

BACKGROUND: Despite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this study is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility. METHODS: This two-phased design will determine the feasibility of CARE-CITE-Gait, a novel intervention that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-h home visits for dyad collaborative goal setting. In phase I, content validity, usability, and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In phase II, feasibility (based on measures of recruitment, retention, intervention adherence, and safety) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, quasi-experimental design with repeated measures (two baseline visits 1 week apart, posttest, and 1-month follow-up) with 15 carepartner and stroke survivor dyads. Outcome data collectors will be blinded. Outcomes include psychosocial variables (family conflict surrounding stroke recovery, strain, autonomy support, and quality of life) collected from carepartners and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors. DISCUSSION: The findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05257928. Registered 25 February 2022. TRIAL STATUS: This trial was registered on ClinicalTrials.gov (NCT05257928) on March 25, 2022. Recruitment of participants was initiated on May 18, 2022.

The EXCITE stroke trial: comparing early and delayed constraint-induced movement therapy.

BACKGROUND AND PURPOSE: Although constraint-induced movement therapy (CIMT) has been shown to improve upper extremity function in stroke survivors at both early and late stages after stroke, the comparison between participants within the same cohort but receiving the intervention at different time points has not been undertaken. Therefore, the purpose of this study was to compare functional improvements between stroke participants randomized to receive this intervention within 3 to 9 months (early group) to participants randomized on recruitment to receive the identical intervention 15 to 21 months after stroke (delayed group). METHODS: Two weeks of CIMT was delivered to participants immediately after randomization (early group) or 1 year later (delayed group). Evaluators blinded to group designation administered primary (Wolf Motor Function Test, Motor Activity Log) and secondary (Stroke Impact Scale) outcome measures among the 106 early participants and 86 delayed participants before delivery of CIMT, 2 weeks thereafter, and 4, 8, and 12 months later. RESULTS: Although both groups showed significant improvements from pretreatment to 12 months after treatment, the earlier CIMT group showed greater improvement than the delayed CIMT group in Wolf Motor Function Test Performance Time and the Motor Activity Log (P<0.0001), as well as in Stroke Impact Scale Hand and Activities domains (P<0.0009 and 0.0214, respectively). Early and delayed group comparison of scores on these measures 24 months after enrollment showed no statistically significant differences between groups. CONCLUSIONS: CIMT can be delivered to eligible patients 3 to 9 months or 15 to 21 months after stroke. Both patient groups achieved approximately the same level of significant arm motor function 24 months after enrollment. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00057018.

Factors associated with depressive symptoms of carepartners of stroke survivors after discharge from rehabilitation therapy.

Background: The long-term consequences of stroke affect both the carepartner (CP) and stroke survivor (SS). Understanding the effects of informal caregiving that may influence the ability of the family to carry over therapeutic activities in the home environment is critical for family-centered care.Objective: This study examined the relationship of CP and SS factors associated with CP depressive symptoms to gain insights into CP needs that may occur after formal rehabilitation therapy has ended for SS with upper extremity deficits.Methods: This correlational study used baseline data of 32 dyads of family CP and SS with upper extremity impairment who had completed rehabilitation therapy and were enrolled in a pilot study of a web-based CP-integrated rehabilitation program. Data using standard questionnaires for CP factors and SS memory and behavior problems and an objective assessment of SS upper extremity function were obtained. Data analysis included descriptive statistics and Pearson product moment correlations.Results: CPs were female (62.5%), White (61.29%), and spouses (68.75%). CPs reported mild-moderate depressive symptoms (M = 9.5 ± 8.3), and a majority had some degree of family conflict. Higher CP depressive symptoms were related to worse life changes (r = -0.41, p =.02), greater fatigue (r = 0.50, p =.004), less effective family functioning (r = 0.46, p =.01), less autonomy support to SS (r = -0.42, p =.02), and more SS memory and behavior problems (r = 0.45, p =.01). Only CP fatigue was related to SS upper extremity function.Conclusions: Negative impacts of caregiving were found in this group of relatively high physically functioning SS which may hinder CP from providing optimal support for SS. Addressing CP needs including education regarding depression, fatigue, SS memory, and behavior problems, and family functioning while SS is receiving rehabilitation therapy may be important considerations to help facilitate the CP to support the SS in carrying over therapeutic activities in the home environment.

Minimal detectable change scores for the Wolf Motor Function Test.

BACKGROUND: The Wolf Motor Function Test (WMFT) is an impairment-based test whose psychometrics have been examined by previous reliability and validity studies. Standards for evaluating whether a given change is meaningful, however, have not yet been addressed. OBJECTIVES: To determine the standard error of measurement (SEM) and minimal detectable change (MDC) for the WMFT. METHODS: Data were collected from 6 university laboratories that participated in the EXCITE national clinical trial and included 96 individuals with sub-acute stroke (3-9 months). Measurements were made by blinded evaluators who were trained and standardized to administer the WMFT, which was completed on 2 occasions 2 weeks apart. No intervention was given between testing sessions. RESULTS: The WMFT Performance Time score has a SEM of 0.2 seconds and a MDC95 of 0.7 seconds. The individual task timed items MDC95 ranged from 1.0 second (turn key in lock) to 3.4 seconds (reach and retrieve) with individual task items demonstrating notably higher variability than the average WMFT Performance Time. The average WMFT Functional Ability Scale SEM and MDC95 is 0.1 points. CONCLUSIONS: When assessing the effect of a therapeutic intervention, if an individual experiences an amount of change equal to or greater than the MDC, then one may be 95% confident that this margin of change is truly larger than measurement error and not a chance result. Thus, the determination of SEM and MDC in outcome assessments allows researchers and clinicians to distinguish which results are actual differences versus which results are simply changes resulting from error or chance.

Long-term follow-up after constraint-induced therapy: a case report of a chronic stroke survivor.

OBJECTIVE: Upper-extremity functional improvements after constraint-induced movement therapy have not been documented beyond 2 years. This case report describes the long-term maintenance of the effects of change 4-5 years after an application of constraint-induced therapy. METHOD: A 36-year-old female poststroke patient participated in constraint-induced therapy for 2 weeks. She was evaluated before and after treatment and again 4 and 5 years later. Primary outcome measures included the Wolf Motor Function Test, Stroke Impact Scale, and Motor Activity Log. RESULTS: Improvements were maintained in reported use and ability of the arm and hand, time to complete functional tasks, and physical aspects of health-related quality of life. Fatigue may have had a moderating effect on the extent of these changes. CONCLUSION: Improved upper-extremity function continued over a 5-year period after constraint-induced therapy; however, poststroke fatigue remained an influential limiting factor.

Family-Centered Care During Constraint-Induced Therapy After Chronic Stroke: A Feasibility Study.

PURPOSE: This feasibility study evaluated a theory-based intervention (CARE-CITE) designed to engage carepartners (CPs) in supporting stroke survivor upper extremity rehabilitation. DESIGN: The study was a one-group design with pre- and posttest and 1 month follow-up (N = 7 dyads). METHODS: Feasibility was determined by participant retention, CP and stroke survivor intervention adherence, and CP acceptability of the intervention (exit interview). Measures of CP depressive symptoms, fatigue, and family conflict around stroke recovery and stroke survivor upper extremity function are reported. Data were analyzed using descriptive statistics. FINDINGS: All participants completed the study and adhered to the intervention, and CPs found CARE-CITE helpful. Descriptively, better scores were observed for CP's mental health, family conflict, stroke survivor confidence, and upper extremity tasks performed. CONCLUSION: These results provide initial evidence that CARE-CITE is feasible after chronic stroke and that CPs and stroke survivors may benefit from family-centered care. CLINICAL RELEVANCE: Improving CP skills in supporting rehabilitation activities may improve stroke survivor upper extremity function.

A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.

BACKGROUND: Family carepartner management and support can improve stroke survivor recovery, yet research has placed little emphasis on how to integrate families into the rehabilitation process without increasing negative carepartner outcomes. Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor. The purpose of this study is to explore a novel, web-based intervention (Carepartner and Constraint-Induced Therapy; CARE-CITE) designed to facilitate positive carepartner involvement during a home-based application of constraint-induced movement therapy (CIMT) for the upper extremity. METHODS: The primary aim of the study is to determine feasibility of CARE-CITE for both stroke survivors and their carepartners. Carepartner mental health, family conflict surrounding stroke recovery, and stroke survivor upper extremity function will be evaluated using an evaluator blinded, two-group experimental design (blocked randomization protocol according to a 2:1 randomization schema) with 32 intervention dyads and 16 control dyads (who will receive CIMT without structured carepartner involvement). CARE-CITE consists of online education modules for the carepartner to review in parallel to the 30-h CIMT that the stroke survivor receives. The intent of CARE-CITE is to enhance the home-based intervention of CIMT, by helping the carepartner support the therapy and create a therapeutic home environment encouraging practice of the weaker arm in functional tasks. DISCUSSION: The CARE-CITE study is testing the feasibility of a family-integrated rehabilitation approach applied in the home environment, and results will provide the foundation for larger clinical studies. The overall significance of this research plan is to increase the understanding and further development of interventions that may serve as models to promote family involvement in the rehabilitation process. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02703532. Registered 9 March 2016.

Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial.

BACKGROUND: The aim of constraint-induced movement therapy (CIMT) is to promote use of a limb that is functionally impaired after a stroke. In one form of CIMT to treat upper limb impairment, use of the less severely affected arm is restricted for many hours each weekday over 2 consecutive weeks. The EXCITE trial has previously shown the efficacy of this intervention for patients 3-9 months poststroke who were followed-up for the next 12 months. We assessed the retention of improvements 24 months after the intervention. METHODS: In the EXCITE trial, 106 of 222 participants who had mild to moderate poststroke impairments were randomly assigned to receive CIMT rather than usual and customary care. We assessed this group of patients every 4 months for the primary outcome measure of impaired upper limb function, as measured with the Wolf motor function test (WMFT) and the motor activity log (MAL). Health-related quality of life, measured with the stroke impact scale (SIS), was a secondary outcome measure. Analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT00057018. FINDINGS: The effects at 24 months after treatment did not decline from those at 12 months for time taken to complete the WMFT (-0.32 s, 95% CI -3.70 to 3.06), for weight lifted in the WMFT (-1.39 kg, -2.74 to -0.04), for WMFT grip strength (-4.39 kg, -6.91 to -1.86), for amount of use in the MAL (-0.17, -0.38 to 0.04), or for how well the limb was used in the MAL (-0.14, -0.34 to 0.06). The additional changes were in the direction of increased therapeutic effect. For the strength components of the WMFT, p<0.0001. INTERPRETATION: Patients who have mild to moderate impairments 3-9 months poststroke have substantial improvement in functional use of the paretic upper limb and quality of life 2 years after a 2-week CIMT intervention. Thus, this intervention has persistent benefits.

Constraint-induced movement therapy in stroke rehabilitation: perspectives on future clinical applications.

Results from studies supporting the application of constraint-induced movement therapy (CI therapy) in patients with stroke have steadily increased over the past decade. The exploration of this intervention has provided a broad foundation from which to build further development of evidence-based practice in neurorehabilitation. This article first provides an update on CI therapy efficacy based on the relative chronicity of stroke and the functional levels of participants from whom data have been acquired. A review of current considerations is discussed, including guidelines for screening criteria, the role of the patient and family during the intervention, options for various delivery modes and suggestions to monitor outcomes. Finally, future directions are explored through identification of integrated approaches with CI therapy including: robotics, virtual environments, mental imagery, pharmaceutical manipulations and cortical stimulation. Clinical application of a research based intervention should not occur in isolation. CI therapy researchers should be charged to define the critical aspects of this therapy and appropriate adjunctive interventions that augment its applicability and effectiveness.

Content validity and satisfaction with a caregiver-integrated web-based rehabilitation intervention for persons with stroke.

Background Family members provide valuable contributions during rehabilitation after stroke, but frequently report higher incidences of burden, depression, and social isolation during caregiving. Thus, effective interventions to reduce stroke impact on the family are needed. Objectives To evaluate the content validity and satisfaction of a caregiver-focused web-based intervention designed to improve stroke survivor physical function while reducing caregiver negative outcomes. Methods Caregivers of individuals with stroke (N = 6) and expert rehabilitation researchers (N = 4) were presented with a novel, web-based intervention (CARE-CITE) designed to foster problem-solving and skill-building while facilitating caregiver involvement during constraint-induced movement therapy. Caregivers rated CARE-CITE for usefulness, ease of use, acceptability, and time to complete. Rehabilitation experts evaluated content for accuracy, feasibility, acceptability, problem relevance and ease of use. Ratings were assessed using a five-point Likert-type response scales (1 = strongly disagree to 5 = strongly agree). Results On average, all caregivers agreed or strongly agreed that the modules were useful (4.42), easy to use (4.60), and acceptable (4.41). Mean total satisfaction score was 4.45, and average review time was 15 min per module. Expert reviewers agreed or strongly agreed that each module was accurate (4.95), feasible (4.8), easy to use (4.86), acceptable (4.96), and had appropriate problem relevance (4.65). Conclusions The CARE-CITE intervention may be a viable program for caregivers of patients with stroke. Currently a pilot study is underway to evaluate the impact of the intervention on caregiver mental health, family conflict around stroke recovery and stroke survivor upper extremity function.

Accelerating Stroke Recovery: Body Structures and Functions, Activities, Participation, and Quality of Life Outcomes From a Large Rehabilitation Trial.

BACKGROUND: Task-oriented therapies have been developed to address significant upper extremity disability that persists after stroke. Yet, the extent of and approach to rehabilitation and recovery remains unsatisfactory to many. OBJECTIVE: To compare a skill-directed investigational intervention with usual care treatment for body functions and structures, activities, participation, and quality of life outcomes. METHODS: On average, 46 days poststroke, 361 patients were randomized to 1 of 3 outpatient therapy groups: a patient-centered Accelerated Skill Acquisition Program (ASAP), dose-equivalent usual occupational therapy (DEUCC), or usual therapy (UCC). Outcomes were taken at baseline, posttreatment, 6 months, and 1 year after randomization. Longitudinal mixed effect models compared group differences in poststroke improvement during treatment and follow-up phases. RESULTS: Across all groups, most improvement occurred during the treatment phase, followed by change more slowly during follow-up. Compared with DEUCC and UCC, ASAP group gains were greater during treatment for Stroke Impact Scale Hand, Strength, Mobility, Physical Function, and Participation scores, self-efficacy, perceived health, reintegration, patient-centeredness, and quality of life outcomes. ASAP participants reported higher Motor Activity Log-28 Quality of Movement than UCC posttreatment and perceived greater study-related improvements in quality of life. By end of study, all groups reached similar levels with only limited group differences. CONCLUSIONS: Customized task-oriented training can be implemented to accelerate gains across a full spectrum of patient-reported outcomes. While group differences for most outcomes disappeared at 1 year, ASAP participants achieved these outcomes on average 8 months earlier (ClinicalTrials.gov: Interdisciplinary Comprehensive Arm Rehabilitation Evaluation [ICARE] Stroke Initiative, at www.ClinicalTrials.gov/ClinicalTrials.gov . Identifier: NCT00871715).