Piloting the efficacy of a home-based telehealth movement-to-music program for increasing physical activity participation among adolescents with cerebral palsy: protocol for a randomized controlled trial (Preprint)
BACKGROUND For adolescents with cerebral palsy (CP) who have mobility limitations, particularly wheelchair users, there are no accessible, inexpensive, and enjoyable home-based programs that can be disseminated on a large-scale to help them independently manage their health through participation in physical activity. OBJECTIVE The primary aim will be to efficacy of a 4-week movement-to-music (M2M) program for increasing physical activity participation compared with a waitlist control group in adolescents with CP. The secondary aim will explore Social Cognitive Theory constructs as potential predictors of change in physical activity levels among participants, to understand the mechanisms through which physical activity changes. The tertiary aim will explore the potential effects of M2M on self-reported levels of two common secondary conditions: pain and fatigue. METHODS This randomized controlled trial will pilot a home-based procedure for implementing a M2M program with behavioral coaching among 68 adolescents with CP who walk or use wheelchairs. Participants will be randomized into one of two groups: a) M2M or b) waitlist control. Waitlist participants will be instructed to maintain their daily activities and will receive the M2M program after completing the 4-week non-intervention period. The M2M program will be packaged into a compilation of video playlists that will be performed by participants three times each week at the home. Outcomes will be measured via questionnaires that will be sent to the participant’s home at baseline and post-intervention. Changes in physical activity participation will be measured via the Children’s Assessment of Participation and Enjoyment. Measured constructs within Social Cognitive Theory will include self-efficacy, goal-setting, self-control, and outcome expectations. Perceived pain, fatigue, and strength will be measured via National Institutes of Health Neuro-QoL and PROMIS pediatric short forms. RESULTS A 2x2 mixed model analysis of variance will be used to examine changes in physical activity. Appropriate regression analyses will be used to associate changes in physical activity scores on Social Cognitive Theory variables. Changes in pain and fatigue levels will be examined using 2x2 mixed model analysis of variance. CONCLUSIONS To date, there is no program that can be easily disseminated by health professionals across multiple sites and settings to promote physical activity among adolescents with CP who have mobility limitations. A low-cost M2M video program that is supplemented with behavioral change strategies has the potential to address this need. This project will determine the efficacy of M2M for increasing physical activity behavior among adolescents with CP, which will determine whether M2M requires further CP-specific modifications before it can be implemented in a larger effectiveness trial. CLINICALTRIAL ClinicalTrials.gov NCT04264390