NCT04264390

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

February 7, 2020

Last Update Submit

October 13, 2021

Conditions

Keywords

exercisephysical activitytelehealth

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

EXPERIMENTAL

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.

Behavioral: Movement-to-music

Wait-list control

NO INTERVENTION

Participants 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.

Also known as: M2M
M2M

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

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.

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Byron W Lai, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
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

Locations