An interventional study of Movement-to-music in Cerebral Palsy, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2021-10-21.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
This study pilots the efficacy of a home-based movement-to-music program for increasing physical activity participation among adolescents with cerebral palsy. Half of the participants will receive the movement-to-music program immediately, which will include 4 weeks of exercise videos and periodic behavioral coaching calls. The other half of participants will wait 4 weeks before receiving the M2M program.
The movement-to-music program has been tested among adults with physical disabilities and is currently being used in ongoing scale-up clinical trials. Current evidence suggests that the program can increase aspects of physical function among adults. The present study aims to test whether the same program can be used among adolescents with cerebral palsy. Study findings will be used to examine whether the videos require modifications prior to being implemented in a future scale-up trial for adolescents people with cerebral palsy.
1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.
This study's enrollment of 59 is above the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive and be instructed to follow-along with 4 weeks of movement-to-music videos. Participants will also receive periodic behavioral coaching calls from a telecoach.
Behavioral: Movement-to-music
Participants will wait 4 weeks before starting the M2M program. Participants will be instructed to resume their normal daily activities during the wait-period.
Movement-to-music is a physical activity program that was developed onsite at a state-of-the-art adapted fitness facility. The program includes movements that are coupled with music to enhance muscular strength, cardiorespiratory capacity, flexibility, and balance. For this study, the program will be packaged into playlists of exercise videos that will be given to participants. Participants will be instructed to complete the prescribed videos 3 times per week. Participants will also be asked to attend 4 behavioral coaching calls with a telecoach. The goals of the behavioral coaching calls will be to address issues with the technology components of the program and promote physical activity participation within the community and adherence to the movement-to-music videos.
Also known as: M2M
Changes in physical activity participation
Participation in home, extracurricular, and community activities measured via the Children's Assessment of Participation and Enjoyment (CAPE). The CAPE is used to document changes in everyday activities outside of the school-setting. The CAPE provides 3 levels of scoring: 1) overall participation scores; 2) domain scores that reflect participation in formal and informal activities; and 3) scores that reflect participation in 5 types of activity (active, physical, recreation, social, skill-based, and self-improvement activities).
Time frame: Baseline and Week 4
Changes in Self-efficacy
Exercise self-efficacy will be measured with the Exercise Self-Efficacy Scale (ESES). The ESES includes 8 items that assess an individual's perceived confidence in the ability to perform more than 40 min of moderate-intensity physical activity three times per week. The ESES is rated on a scale ranging from 0 (Not at all confident) to 100 (Completely confident). The scores are summed into a composite score that ranges between 0 and 100, where a higher score is indicative of a greater perceived level of confidence to participate in physical activity.
Time frame: Baseline and Week 4
Changes in Goal-setting
The EGS contains 10-items related to how an individual sets goals and plans exercise activities. Questions for each of the 2 subcategories (goal setting and planning) are scored on a 5-point scale ranging from 1 (does not describe) to 5 (describes completely). A higher score for the goal-setting subcategory reflects a greater skillset for setting and achieving goals. A higher score in the planning subcategory reflects a greater perceived ability to schedule exercise within the person's lifestyle.
Time frame: Baseline and Week 4
Changes in Social support
Social support will be measured by the Physical Activity Climate Questionnaire (PACQ), which was modified from a 12-item version of the questionnaire that demonstrated discriminant and convergent validity to assess physical activity climate among youth. The PACQ is a 15-item child-report measure of the perceived motivational 'climate' or autonomous support provided by the caregiver with regard to physical activity participation. Due to the nature of the questions, participants will be instructed to complete the PACQ without parental assistance. Questions are scored on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher average scores reflect a higher level of child-perceptions of autonomous support for physical activity behavior.
Time frame: Baseline and Week 4
Changes in Outcome expectations
Outcome expectations will be measured by the Multidimensional Outcomes Expectations for Exercise Scale (MOEES). The MOEES contains 15-items that assess three domains of outcome expectations, namely, physical, social, and self-evaluative outcome expectations. Questions are scored on a 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) and totaled for each outcome expectation category.
Time frame: Baseline and Week 4
Video Minutes Completed Throughout the Intervention (Adherence)
Adherence is defined as the number of movement-to-music video minutes completed throughout the program. The video minutes are objectively recorded via YouTube analytics. Participant's baseline characteristics will be regressed on video minutes, to explain who the program worked for.
Time frame: Week 1 through Week 4
Changes in Perceived Pain
Perceived pain will be measured via the National Institutes of Health Neuro-QoL Pediatric Pain short form.
Time frame: Baseline and Week 4
Changes in Perceived Fatigue
Perceived fatigue will be measured via the the National Institutes of Health Neuro-QoL Pediatric Fatigue short form.
Time frame: Baseline and Week 4
Plan to share: No
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University of Alabama at Birmingham