Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial
M2MCP
Piloting a Novel Home-based Telehealth Movement-to-music Program (M2M) for Increasing Physical Activity Among Adolescents With Cerebral Palsy: Protocol for a Randomized Controlled Trial
1 other identifier
interventional
59
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedOctober 21, 2021
October 1, 2021
12 months
February 7, 2020
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline and Week 4
Secondary Outcomes (5)
Changes in Self-efficacy
Baseline and Week 4
Changes in Goal-setting
Baseline and Week 4
Changes in Social support
Baseline and Week 4
Changes in Outcome expectations
Baseline and Week 4
Video Minutes Completed Throughout the Intervention (Adherence)
Week 1 through Week 4
Other Outcomes (2)
Changes in Perceived Pain
Baseline and Week 4
Changes in Perceived Fatigue
Baseline and Week 4
Study Arms (2)
M2M
EXPERIMENTALParticipants 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.
Wait-list control
NO INTERVENTIONParticipants will wait 4 weeks before starting the M2M program. Participants will be instructed to resume their normal daily activities during the wait-period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of cerebral palsy
- Be able to exercise with arms or be assisted through the movements by a parent
- Be between the ages of 10-19 years
- Have access to a Wi-Fi Internet connection at your home
- Have access to a device that Is capable of viewing videos from YouTube (a television, computer tablet, laptop, or desktop)
You may not qualify if:
- Does more than 60 minutes of moderate-to-vigorous physical activity per day in a normal week
- Has complete blindness or deafness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Related Publications (1)
Lai B, Vogtle L, Young R, Craig M, Kim Y, Gowey M, Swanson-Kimani E, Davis D, Rimmer JH. Telehealth Movement-to-Music to Increase Physical Activity Participation Among Adolescents With Cerebral Palsy: Pilot Randomized Controlled Trial. JMIR Form Res. 2022 Oct 28;6(10):e36049. doi: 10.2196/36049.
PMID: 36306154DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byron W Lai, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 11, 2020
Study Start
September 16, 2020
Primary Completion
September 7, 2021
Study Completion
September 30, 2021
Last Updated
October 21, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share