Child and Caregiver Perspectives of a Combined Brain Stimulation and Constraint-Induced Movement Therapy Trial

PURPOSE: Feedback and satisfaction following participation in a clinical trial are rarely collected and incorporated into future study designs. This lack of information hinders the development of salient interventions and negatively impacts the clinical translation of the interventions. The purpose of this study is to report the perspective of child participants with unilateral cerebral palsy (UCP) and their caregivers’ feedback after participating in an interventional clinical trial combining noninvasive brain stimulation (NIBS) with constraint-induced movement therapy (CIMT). Understanding these perspectives is critical to designing novel interventions that in turn promote recruitment, enrollment, and retention.

DESIGN: This study reports quantitative and qualitative data reflecting the perspectives of participants and caregivers interviewed at the 6-mo follow-up to a larger clinical trial. Our study (clinicaltrials.gov NCT02250092) completed the recruitment of children ages 8–21 with UCP. Additional criteria required the ability to perform activities with the weaker hand and no seizures within the past 2 yr. Assessment included NIBS, neuroimaging, and behavioral outcomes. Intervention consisted of 10 2-hr CIMT sessions with a combinatory initial 20 min of brain stimulation (transcranial direct current stimulation, real or control) occurring in a camp setting.

METHOD: Preliminary data analysis from satisfaction and feedback surveys completed by the eight participants and caregivers at the 6-mo follow-up were reviewed. Satisfaction surveys included rating of the study (scale of 1–10), willingness to repeat the study (yes–no), and willingness to refer a friend (yes–no). Family feedback questions focused on the research experience, preparation, preferred and nonpreferred activities, and questions exploring how to change the study. Themes were identified from recorded interviews.

RESULTS: Average age was 12.4 ± 3.3 yr, and mean satisfaction was reported as 8.0 ± 2.8. Of the eight participants, seven reported willingness to repeat the study, and seven reported willingness to refer a friend. Interview themes included (1) preparedness challenges—“some idea of what to expect . . . but not exactly,” (2) awareness of disability following study completion—“everyone is different,” and (3) caregiver desire for long-term independence—“you just got to let them do it.”

Variability in preparedness among participants impacted their perspective of the study. Caregivers described strategies that aided in their successful completion of the study. Participants reported awareness of their disability after the study as several hadn’t recently been in therapy, and caregivers reported that often the child had not disclosed the disability to peers. Caregiver interviews highlighted the struggle to find a balance between directly helping versus allowing the child to be independent. Caregivers stated they were willing to support their children to participate in early phase trials because they desired new interventions and were eager to contribute to further UCP research.

CONCLUSION: This study examined trial feedback laying the groundwork for future studies that consider the participant experience. Feedback themes focused on preparation, including disability awareness, for pediatric trials is warranted and likely to improve long-term retention and study completion. Collecting trial feedback may allow insight into the child’s and family’s immediate and long-term needs. Further, integrating feedback will impact the success of translating novel interventions to the clinic as it allows for the participant’s voice to be heard and considered as we aim to develop new occupation-based interventions for the future.