Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial

Cerebral Palsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264390
• Other study ID #: AACPDMJIA012001
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 30, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Movement-to-music
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Academy for Cerebral Palsy and Developmental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Perceived Pain	Perceived pain will be measured via the National Institutes of Health Neuro-QoL Pediatric Pain short form.	Baseline and Week 4
Other	Changes in Perceived Fatigue	Perceived fatigue will be measured via the the National Institutes of Health Neuro-QoL Pediatric Fatigue short form.	Baseline and Week 4
Primary	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	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.	Baseline and Week 4
Secondary	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.	Baseline and Week 4
Secondary	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.	Baseline and Week 4
Secondary	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.	Baseline and Week 4
Secondary	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.	Week 1 through Week 4