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.

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.

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.

Statistical inference through estimation: recommendations from the International Society of Physiotherapy Journal Editors / Inferencia estadística a través de la estimación: Recomendaciones de la Sociedad Internacional de Editores de Revistas de Fisioterapia

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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.

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.

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.

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).