Abstract
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.