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Cerebral PalsyPhase 1NCT05619211

Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities

A Phase 1 study testing Sprint-Intensity Interval Training with Telecoaching in people with Cerebral Palsy, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is investigating the potential effects of a high-intensity home-exercise program among children with cerebral palsy. The program includes rhythmic movements to music that are adapted for wheelchair uses and age-appropriate themes. Read more about this study

Who is it for?
Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy
What is being tested?
Sprint-Intensity Interval Training with Telecoaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
29 Sep 2023to 18 Dec 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • have a medical diagnosis of cerebral palsy, as determined by ICD-10 codes
  • aged 6-17 years old
  • a Gross Motor Function Classification System Level I-IV (as determined via participant screening, explained in the protocol section below)
  • medical clearance to participate in high-intensity exercise from a physician (using the attached medical screening form and explained in the intervention safety, monitoring, and response plan)
  • access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
  • a caregiver who will support and monitor the participant's safety during the intervention and manage the child's exercise schedule.

Who cannot join

  • physically active (defined as >150 minutes per week of self-reported moderate-to-vigorous intensity exercise in a typical week)
  • cannot use their arms for exercise
  • a Gross Motor Function Classification Level of V
  • complete blindness or deafness;
  • Any past history of a contraindication to exercise testing according to American College of Sports Medicine (ACSM) guidelines (Liguori and American College of Sports Medicine, 2020): significant change in the resting electrocardiogram suggesting significant ischemia, myocardial infarction, or other cardiac event, unstable angina, uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, pulmonary embolus or pulmonary infarction, myocarditis or pericarditis, aneurysm.
  • pregnant (due to radiation from a Dual Energy X-ray Absorptiometry [DEXA] scan)
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  • has not been seen by a physician within the last year
  • uses a g-tube
  • Eligible caregivers will include parents or legal guardians of the child, who can commit sufficient time to support the child in their roles for the study and communicate in English. Caregivers who have complete blindness or deafness will be excluded from participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wellness Health And Research Facility (WHARF)

    Homewood, Alabama, 35209

Other trials in United States

About this study

Official title: Improving Cardiorespiratory Fitness and Cardiometabolic Health Among Children With Physical Disabilities Through Movement-to-Music Telehealth With Arm-based Sprint-Intensity Interval Training

This study is investigating the potential effects of a high-intensity home-exercise program among children with cerebral palsy. The program includes rhythmic movements to music that are adapted for wheelchair uses and age-appropriate themes. This project has the potential to address a large knowledge gap in the extant literature, because there are no widely accessible, evidence-based, enjoyable, and age-appropriate modalities for improving cardiovascular fitness or cardiometabolic health among children with disabilities who have mobility disabilities.

Conditions
Cerebral Palsy
Being tested
Sprint-Intensity Interval Training with Telecoaching
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sprint-Intensity Interval Training with TelecoachingBehavioural

    Maximal intensity exercises that use the arms.

Study groups in NCT05619211
Study groupRoleWhat they receive
Movement-to-MusicExperimental12 weeks of sprint-intensity interval training while following along with YouTube videos that include arm-based routines, with coaching through telecommunications. Participants are instructed to maintain their habitual diet and nutrition patterns
Receives: Behavioral: Sprint-Intensity Interval Training with Telecoaching
Wait-list ControlNo intervention12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in pVO2

    peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

Secondary outcomes (13)

  1. Change in Body Weight

    body weight in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  2. Changes in Total Body Fat

    body fat in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  3. Changes in Total Lean Mass

    lean mass in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  4. Changes in Lean Tissue Percentage

    percentage of lean tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  5. Changes in Fat Tissue Percentage

    percentage of fat tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  6. Changes in C-reactive Protein

    hsCRP (mg/L) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  7. Changes in Hemoglobin A1C

    HbA1C (mmol/mol) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  8. Changes in Fasting Insulin

    Fasting Insulin (μIU/mL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  9. Changes in Fasting Triglycerides

    Fasting Triglycerides (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  10. Changes in Fasting High-density Lipoprotein

    HDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  11. Changes in Fasting Low-density Lipoprotein

    LDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  12. Changes in Systolic Blood Pressure

    systolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

  13. Changes in Diastolic Blood Pressure

    diastolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.

    Measured: Week 0, Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start29 Sep 2023
  3. Primary completion1 Nov 2025
  4. Study completion18 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619211
Sponsor's protocol ID
IRB-300010372
Other IDs
1R21HD109358-01A1
Status last verified
Mar 2026
First submitted
2 Nov 2022
Last updated
2 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be submitted into the NICHD Data and Specimen Hub (DASH). Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance under notice NOT-OD-03-032 (released February 26, 2003)

Publications

  • Lai B, Oster RA, Davis D, Bright L, Fisher G, Wilroy J, Kim Y, Young R, Wright A, Sinha T, Rimmer JH. Telehealth Movement-to-Music With Arm-Based Sprint-Intensity Interval Training to Improve Cardiometabolic Health and Cardiorespiratory Fitness in Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 5;13:e56499. doi: 10.2196/56499.

    PubMed 38441939

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sprint-Intensity Interval Training with Telecoaching in people with Cerebral Palsy, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in pVO2 (time frame: Week 0, Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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