Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial (M2MCP)
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement-to-music
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring exercise, physical activity, telehealth
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Alabama
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
M2M
Wait-list control
Arm Description
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.
Participants will wait 4 weeks before starting the M2M program. Participants will be instructed to resume their normal daily activities during the wait-period.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04264390
First Posted
February 7, 2020
Last Updated
October 13, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
American Academy for Cerebral Palsy and Developmental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04264390
Brief Title
Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial
Acronym
M2MCP
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Academy for Cerebral Palsy and Developmental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
exercise, physical activity, telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M2M
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Participants will wait 4 weeks before starting the M2M program. Participants will be instructed to resume their normal daily activities during the wait-period.
Intervention Type
Behavioral
Intervention Name(s)
Movement-to-music
Other Intervention Name(s)
M2M
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in physical activity participation
Description
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
Secondary Outcome Measure Information:
Title
Changes in Self-efficacy
Description
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
Title
Changes in Goal-setting
Description
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
Title
Changes in Social support
Description
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
Title
Changes in Outcome expectations
Description
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
Title
Video Minutes Completed Throughout the Intervention (Adherence)
Description
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
Other Pre-specified Outcome Measures:
Title
Changes in Perceived Pain
Description
Perceived pain will be measured via the National Institutes of Health Neuro-QoL Pediatric Pain short form.
Time Frame
Baseline and Week 4
Title
Changes in Perceived Fatigue
Description
Perceived fatigue will be measured via the the National Institutes of Health Neuro-QoL Pediatric Fatigue short form.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron W Lai, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36306154
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.
Results Reference
derived
Learn more about this trial
Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial
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