Clinical trial NCT04264390: Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: exercise
physical activity
telehealth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Academy of Cerebral Palsy and Developmental Medicine
First posted: 2020-02-11
Enrollment: 59
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of cerebral palsy
2. Be able to exercise with arms or be assisted through the movements by a parent
3. Be between the ages of 10-19 years
4. Have access to a Wi-Fi Internet connection at your home
5. Have access to a device that Is capable of viewing videos from YouTube (a television, computer tablet, laptop, or desktop)

Exclusion Criteria:

1. Does more than 60 minutes of moderate-to-vigorous physical activity per day in a normal week
2. Has complete blindness or deafness

Primary outcomes:
measure: Changes in physical activity participation
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Changes in Self-efficacy
timeFrame: Baseline and Week 4
measure: Changes in Goal-setting
timeFrame: Baseline and Week 4
measure: Changes in Social support
timeFrame: Baseline and Week 4
measure: Changes in Outcome expectations
timeFrame: Baseline and Week 4
measure: Video Minutes Completed Throughout the Intervention (Adherence)
timeFrame: Week 1 through Week 4
Other outcomes:
measure: Changes in Perceived Pain
timeFrame: Baseline and Week 4
measure: Changes in Perceived Fatigue
timeFrame: Baseline and Week 4
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Byron W Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.