CompletedNCT05619211Updated Apr 2, 2026Results posted

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

A Phase 1 interventional study of Sprint-Intensity Interval Training with Telecoaching in Cerebral Palsy, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by University of Alabama at Birmingham · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study 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. 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 studied

Cerebral Palsy

Browse trials for

Cerebral Palsy 1,853

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 42 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

We are recruiting 50 parent-child dyads. Childs are the participant undergoing the exercise intervention. Parents are required to support the safety and schedule of the child participant. Parents are considered participants due to their responsibilities.

Inclusion criteria

Inclusion Criteria:

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.

Exclusion criteria

Exclusion Criteria:

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)
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 42 participants (actual)

Study arms

Experimental
Movement-to-Music
12 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
Behavioral: Sprint-Intensity Interval Training with Telecoaching
No intervention
Wait-list Control
12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music

Interventions

BehavioralSprint-Intensity Interval Training with Telecoaching
Maximal intensity exercises that use the arms.

What researchers measure

Primary outcomes

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.
Time frame: Week 0, Week 13

Secondary outcomes

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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 13
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.
Time frame: Week 0, Week 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.
Time frame: Week 0, Week 13

Other outcomes

Adherence to the Exercise Prescription
Percentage of sessions attended versus prescribed. Data represents the child participant. Outcome measures were not collected for the parent participant.
Time frame: Week 1 - 12
Number of Participants With Adverse Events
Any adverse event reported by participants (e.g., injury). Data represents the child participant. Outcome measures were not collected for the parent participant.
Time frame: Week 1 - 12

Results

Posted Apr 2, 2026

Participant flow

This study enrolled child-caregiver dyads.

Digital Consent

Participant flow — Digital Consent
Milestone	Movement-to-Music	Wait-list Control
Started	22	20
Completed	20	19
Not completed	2	1

Enrolled

Participant flow — Enrolled
Milestone	Movement-to-Music	Wait-list Control
Started	20	19
Completed	19	19
Not completed	1	0
Withdrew: Withdrawal by subject	1	0

Outcome measures

PrimaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mL/kg-1/min-1

Changes in pVO2
mL/kg-1/min-1	Movement-to-Music	Wait-list Control
Changes in pVO2	1.72 (0.52 to 2.91)	-0.61 (-1.77 to 0.55)

SecondaryChange 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · Kg

Change in Body Weight
Kg	Movement-to-Music	Wait-list Control
Change in Body Weight	0.53 (-0.60 to 1.66)	1.38 (0.28 to 2.47)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · Kg

Changes in Total Body Fat
Kg	Movement-to-Music	Wait-list Control
Changes in Total Body Fat	0.03 (-0.99 to 1.05)	1.22 (0.24 to 2.21)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · Kg

Changes in Total Lean Mass
Kg	Movement-to-Music	Wait-list Control
Changes in Total Lean Mass	0.47 (-3.50 to 4.43)	3.07 (-0.77 to 6.91)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · percentage of lean mass

Changes in Lean Tissue Percentage
percentage of lean mass	Movement-to-Music	Wait-list Control
Changes in Lean Tissue Percentage	0.81 (-0.30 to 1.93)	-0.21 (-1.29 to 0.88)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · percentage of fat mass

Changes in Fat Tissue Percentage
percentage of fat mass	Movement-to-Music	Wait-list Control
Changes in Fat Tissue Percentage	-0.23 (-2.68 to 2.22)	1.72 (-0.66 to 4.09)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mg/L

Changes in C-reactive Protein
mg/L	Movement-to-Music	Wait-list Control
Changes in C-reactive Protein	-0.29 (-1.85 to 1.26)	0.31 (-1.12 to 1.75)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mmol/mol

Changes in Hemoglobin A1C
mmol/mol	Movement-to-Music	Wait-list Control
Changes in Hemoglobin A1C	0.10 (-0.15 to 0.36)	0.08 (-0.18 to 0.32)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · μIU/mL

Changes in Fasting Insulin
μIU/mL	Movement-to-Music	Wait-list Control
Changes in Fasting Insulin	-6.61 (-10.98 to -2.23)	-0.95 (-5.39 to 3.49)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mg/dL

Changes in Fasting Triglycerides
mg/dL	Movement-to-Music	Wait-list Control
Changes in Fasting Triglycerides	-12.93 (-30.06 to 4.20)	4.63 (-12.20 to 21.45)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mg/dL

Changes in Fasting High-density Lipoprotein
mg/dL	Movement-to-Music	Wait-list Control
Changes in Fasting High-density Lipoprotein	-6.46 (-12.38 to -0.53)	-2.63 (-8.37 to 3.12)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mg/dL

Changes in Fasting Low-density Lipoprotein
mg/dL	Movement-to-Music	Wait-list Control
Changes in Fasting Low-density Lipoprotein	-15.10 (-32.48 to 2.29)	0.94 (-15.56 to 17.44)

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mmHg

Changes in Systolic Blood Pressure
mmHg	Movement-to-Music	Wait-list Control
Changes in Systolic Blood Pressure	0.87 ± 12	0.77 ± 7

SecondaryChanges 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.

Time frame:: Week 0, Week 13
Reported as:: Mean · mmHg

Changes in Diastolic Blood Pressure
mmHg	Movement-to-Music	Wait-list Control
Changes in Diastolic Blood Pressure	-1.7 ± 12	2.8 ± 4

Other pre-specifiedAdherence to the Exercise Prescription

Percentage of sessions attended versus prescribed. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame:: Week 1 - 12
Reported as:: Mean · percentage of sessions attended

Adherence to the Exercise Prescription
percentage of sessions attended	Movement-to-Music
Adherence to the Exercise Prescription	90 ± 22

Other pre-specifiedNumber of Participants With Adverse Events

Any adverse event reported by participants (e.g., injury). Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame:: Week 1 - 12
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events
Participants	Movement-to-Music	Wait-list Control
Number of Participants With Adverse Events	0	0

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Movement-to-Music	0/20 (0%)	0/20 (0%)	0/20 (0%)
Wait-list Control	0/19 (0%)	0/19 (0%)	0/19 (0%)

Baseline characteristics

Baseline data was only collected for the child. Thus, baseline characteristics represent the child participant.

Age, Continuous
Age, Continuous(years)	Movement-to-Music	Wait-list Control	Total
Mean	12.3 ± 3.2	12.1 ± 3.5	12.2 ± 3.3

Sex: Female, Male
Sex: Female, Male(Participants)	Movement-to-Music	Wait-list Control	Total
Female	10	10	20
Male	10	9	19

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Movement-to-Music	Wait-list Control	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	19	19	38
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Movement-to-Music	Wait-list Control	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	7	6	13
White	11	12	23
More than one race	2	0	2
Unknown or Not Reported	0	1	1

Gross Motor Function Classification Scale (GMFCS)
Gross Motor Function Classification Scale (GMFCS)(Participants)	Movement-to-Music	Wait-list Control	Total
I	16	12	28
II	0	2	2
III	2	4	6
IV	2	1	3

Study locations

1 site

Wellness Health And Research Facility (WHARF)
Homewood, Alabama 35209, United States

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan · Nov 7, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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)

Supporting information: Study protocol

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05619211
Lead sponsor: University of Alabama at Birmingham
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Byron Lai (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted: Nov 16, 2022
Start date: Sep 29, 2023
Primary completion: Nov 1, 2025
Completion: Dec 18, 2025
Results posted: Apr 2, 2026
Last update: Apr 2, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cerebral Palsy→

Other studies from this sponsor

University of Alabama at Birmingham

Start the discussion