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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's Hospital of Alabama

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • M2M
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in physical activity participation
Time Frame: Baseline and Week 4
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline and Week 4
Changes in Goal-setting
Time Frame: Baseline and Week 4
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
Changes in Social support
Time Frame: Baseline and Week 4
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
Changes in Outcome expectations
Time Frame: Baseline and Week 4
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
Video Minutes Completed Throughout the Intervention (Adherence)
Time Frame: Week 1 through Week 4
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Perceived Pain
Time Frame: Baseline and Week 4
Perceived pain will be measured via the National Institutes of Health Neuro-QoL Pediatric Pain short form.
Baseline and Week 4
Changes in Perceived Fatigue
Time Frame: Baseline and Week 4
Perceived fatigue will be measured via the the National Institutes of Health Neuro-QoL Pediatric Fatigue short form.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Academy for Cerebral Palsy and Developmental Medicine

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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