Understanding factors contributing to participant satisfaction in stroke walking recovery clinical trials.

ABSTRACT

Background: Individuals with stroke face a distinct set of challenges, barriers and facilitators that need to be understood to streamline efficacy of stroke clinical trials and improve participant retention. Few long-term stroke rehabilitation trials have evaluated participant perception of their laboratory experience. Methods: We collected data regarding trial satisfaction from 33 individuals with stroke who participated in 12 sessions of treadmill training which included pre, post and follow-up non-invasive brain stimulation and clinical assessments. We evaluated factors such as overall trial satisfaction, burden of testing, perceived benefits, perceived barriers, and perceived support using a participant satisfaction questionnaire (PSQ) that assessed participants' overall trial experience. Results: 97% of our participants found participating in the study to be rewarding and would recommend it to other persons with stroke. Transcranial magnetic stimulation (TMS) testing was found to be the major perceived burden of participation while travelling to the lab was found to be the major perceived barrier to participation. Significant correlations were found between various items of the PSQ and clinical assessments. Conclusions: This study helped us get a preliminary perspective into the benefits and barriers faced by persons with stroke enrolled in a 4-week long clinical trial. We observed that participant satisfaction was driven by various factors including functional status, personal relevance to the research, perceptive physical and mental health improvements, interaction with research personnel, and ease of testing protocols.