Blanton Sarah, Cotsonis George, Brennan Kayla, Song Robert, Zajac-Cox Laura, Caston Sarah, Stewart Heather, Jayaraman Arun, Reisman Darcy, Clark Patricia C, Kesar Trisha
Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, 1441 Clifton Road NE, Room 213, Atlanta, GA, 30322, USA.
Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, 1518 Clifton Road, NE, Atlanta, GA, 30322, USA.
Pilot Feasibility Stud. 2023 Nov 24;9(1):192. doi: 10.1186/s40814-023-01411-1.
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.
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.
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.
ClinicalTrials.gov, NCT05257928. Registered 25 February 2022.
This trial was registered on ClinicalTrials.gov (NCT05257928) on March 25, 2022. Recruitment of participants was initiated on May 18, 2022.
尽管中风患者的家庭护理伙伴承受着高水平的压力且生活质量下降，但中风康复干预很少关注护理伙伴的福祉，也很少提供培训以支持他们参与治疗活动。我们的团队开发了创新性的干预方法，在中风康复期间为家庭提供支持，从而改善护理伙伴和中风幸存者的身体及心理社会结局。本研究的目的是测试一种经过调整的居家干预措施（针对步态的护理伙伴协作综合疗法 - CARE-CITE-步态）的可行性，该干预旨在促进护理伙伴在针对步态和移动性的居家训练中积极参与。
这种两阶段设计将确定CARE-CITE-步态这一新型干预措施的可行性，该干预借鉴了我们之前针对护理伙伴的上肢干预原则。在为期4周的CARE-CITE-步态干预期间，护理伙伴观看基于视频的在线模块，这些模块旨在阐述在功能性移动任务练习中营造自主性支持环境的策略，研究团队进行两次为时2小时的家访，以进行二元协作目标设定。在第一阶段，中风康复内容专家和护理伙伴将评估CARE-CITE-步态模块的内容效度、可用性和可接受性。在第二阶段，将测量可行性（基于招募、留存、干预依从性和安全性的指标）。CARE-CITE-步态的初步效果将通过单组准实验设计收集，该设计采用重复测量（两次间隔1周的基线访视、后测和1个月随访），涉及15对护理伙伴和中风幸存者。结局数据收集者将保持盲态。结局包括从护理伙伴处收集的心理社会变量（围绕中风康复的家庭冲突、压力、自主性支持和生活质量），以及从中风幸存者处收集的功能性移动性、步速、跨步活动和健康相关生活质量的测量指标。
可行性测试的结果以及关于CARE-CITE-步态效果的初步数据将为未来确定的随机临床试验提供依据和信息。从本研究中获得的知识将增进我们对中风康复过程中满足护理伙伴和中风幸存者需求的康复方法的理解，并有助于其发展。
ClinicalTrials.gov，NCT05257928。2022年2月25日注册。
本试验于2022年3月25日在ClinicalTrials.gov（NCT05257928）上注册。2022年5月18日开始招募参与者。
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