- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264390
Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial (M2MCP)
October 13, 2021 updated by: Byron Lai, University of Alabama at Birmingham
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 19 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Does more than 60 minutes of moderate-to-vigorous physical activity per day in a normal week
- Has complete blindness or deafness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: M2M
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.
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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.
Other Names:
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NO_INTERVENTION: Wait-list control
Participants will wait 4 weeks before starting the M2M program.
Participants will be instructed to resume their normal daily activities during the wait-period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in physical activity participation
Time Frame: Baseline and Week 4
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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).
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Baseline and Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Self-efficacy
Time Frame: Baseline and Week 4
|
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.
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Baseline and Week 4
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Changes in Goal-setting
Time Frame: Baseline and Week 4
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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.
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Baseline and Week 4
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Changes in Social support
Time Frame: Baseline and Week 4
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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.
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Baseline and Week 4
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Changes in Outcome expectations
Time Frame: Baseline and Week 4
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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.
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Baseline and Week 4
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Video Minutes Completed Throughout the Intervention (Adherence)
Time Frame: Week 1 through Week 4
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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.
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Week 1 through Week 4
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Perceived Pain
Time Frame: Baseline and Week 4
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Perceived pain will be measured via the National Institutes of Health Neuro-QoL Pediatric Pain short form.
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Baseline and Week 4
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Changes in Perceived Fatigue
Time Frame: Baseline and Week 4
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Perceived fatigue will be measured via the the National Institutes of Health Neuro-QoL Pediatric Fatigue short form.
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Baseline and Week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 16, 2020
Primary Completion (ACTUAL)
September 7, 2021
Study Completion (ACTUAL)
September 30, 2021
Study Registration Dates
First Submitted
February 7, 2020
First Submitted That Met QC Criteria
February 7, 2020
First Posted (ACTUAL)
February 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 21, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AACPDMJIA012001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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