ClinicalTrials.gg
CompletedNCT06455930Updated Sep 24, 2026Results posted

Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy

An interventional study of Stand-on ride-on power mobility device in Cerebral Palsy, sponsored by University of North Florida. Completed at 1 site in United States. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by University of North Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
4 Years to 6 Years
Sex
All
01

Study summary

The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD).

The main questions we aim to answer are:

  • How does the use of stand-on PMDs affect static balance in children with cerebral palsy?
  • How does the use of stand-on PMDs affect dynamic balance and mobility function in children with cerebral palsy?

Children ages 4-6 years old with cerebral palsy (GMFCS levels II and III) will:

  • Use individually-adapted stand-on PMDs for three months.
  • Undergo tests to measure static balance, dynamic balance, and mobility function before and after the intervention.
  • Receive a full biomechanical assessment (kinematics, kinetics, muscle activity, gait spatiotemporal characteristics).

Researchers will compare pre-intervention and post-intervention measurements to quantify improvements in balance, muscle activation, and mobility.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • Cerebral Palsy
  • Power Mobility Device
  • Balance
  • Muscle activity
  • Mobility
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's enrollment of 10 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University of North Florida is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of spastic diplegia CP, GMFCS level III;
  2. Between 4 and 6 years old (age band selected based on the benefits of early intervention and the age-limitation imposed from the size constraints of the PMDs (toy cars) selected for the intervention);
  3. Able to stand and to walk short distances (at least 10 meters) with or without external assistance;
  4. Physician medical clearance to participate; and
  5. Exhibit sufficient cooperation and attention so that simple verbal instructions can be followed.

Exclusion criteria

Exclusion Criteria:

  1. Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening);
  2. Inadequate vision to complete study's procedures safely;
  3. Serious/unstable cardiac conditions that prevent engagement in the Evaluation Sessions; and
  4. Any other factor that might hinder full participation in the study or confound interpretation of the results.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Children with cerebral palsy received an individually adapted stand-on ride-on powered mobility device for home and community use over a three-month intervention period. Participants completed biomechanical assessments before and after the intervention.

    Device: Stand-on ride-on power mobility device

Interventions

  • DeviceStand-on ride-on power mobility device

    Children will receive the adapted toy car (individually-adapted stand-on PMD) to take home and use for three months. PMD will be used at their house and familiar environments to the family (e.g., neighborhood, parks, schools).

06

What researchers measure

Primary outcomes

  1. Center of Pressure Sway Area, Standing

    Center of pressure sway area during quiet standing was quantified as the 95% confidence ellipse area derived from force plate measurements. Larger sway area values indicate greater postural sway and reduced standing balance stability. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple standing trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

    Time frame: Pre (immediately before intervention), Post (3 months post Pre)

Secondary outcomes

  1. Center of Pressure Sway Area, Sit-to-stand

    Measure of dynamic balance control during sit-to-stand. Center of pressure sway area during quiet standing was quantified as the 95% confidence ellipse area derived from force plate measurements. Larger ellipse areas indicate greater postural sway. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple standing trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

    Time frame: Pre (immediately before intervention), Post (3 months post Pre)

  2. Trunk-pelvis Coupling

    Quantification of timing and magnitude of whole-body motor control coordination during functional tasks (e.g., sit-to-stand, walking turns). Trunk-pelvis coupling was quantified using vector coding analysis to characterize coordination between trunk and pelvis motion during the movement task. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

    Time frame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)

07

Results

Posted Aug 28, 2026

Participant flow

Participants with cerebral palsy were recruited through clinical and community outreach associated with the University of North Florida. Eligible participants completed baseline, pre, and post-intervention assessments during participation in the stand-on powered mobility intervention study.

Participant flow — Overall Study
MilestoneIntervention Group
Started10
Baseline assessment10
Pre-intervention assessment10
Post-intervention assessment9
Completed9
Not completed1
Withdrew: Lost to follow-up1

Outcome measures

PrimaryCenter of Pressure Sway Area, Standing

Center of pressure sway area during quiet standing was quantified as the 95% confidence ellipse area derived from force plate measurements. Larger sway area values indicate greater postural sway and reduced standing balance stability. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple standing trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

Time frame:
Pre (immediately before intervention), Post (3 months post Pre)
Reported as:
Median · mm^2
Center of Pressure Sway Area, Standing
mm^2Intervention Group
Pre-Intervention COP Ellipse Area1670.171 (1122.309 to 2022.642)
Post-Intervention COP Ellipse Area521.777 (263.567 to 1830.514)
SecondaryCenter of Pressure Sway Area, Sit-to-stand

Measure of dynamic balance control during sit-to-stand. Center of pressure sway area during quiet standing was quantified as the 95% confidence ellipse area derived from force plate measurements. Larger ellipse areas indicate greater postural sway. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple standing trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

Time frame:
Pre (immediately before intervention), Post (3 months post Pre)
Reported as:
Median · mm^2
Center of Pressure Sway Area, Sit-to-stand
mm^2Intervention Group
Pre-Intervention COP Ellipse Area2186.212 (1469.301 to 2788.919)
Post-Intervention COP Ellipse Area2528.908 (851.538 to 3852.605)
SecondaryTrunk-pelvis Coupling

Quantification of timing and magnitude of whole-body motor control coordination during functional tasks (e.g., sit-to-stand, walking turns). Trunk-pelvis coupling was quantified using vector coding analysis to characterize coordination between trunk and pelvis motion during the movement task. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

Time frame:
Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Reported as:
Median · Degrees
Trunk-pelvis Coupling
DegreesIntervention Group
Pre-Intervention Coupling Angle120.805 (103.137 to 138.03)
Post-Intervention Coupling Angle110.798 (107.562 to 131.337)

Adverse events

Collected over From enrollment until two weeks after post-assessment, up to 26 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Children with cerebral palsy received an individually adapted stand-on ride-on powered mobility device for home and community use over a three-month intervention period. Participants completed biomechanical assessments before and after the intervention.

Age, Continuous
Age, Continuous(Years)Intervention Group
Mean4.8 ± 0.9189
Sex: Female, Male
Sex: Female, Male(Participants)Intervention Group
Female6
Male4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention Group
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White7
More than one race1
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention Group
Hispanic or Latino3
Not Hispanic or Latino7
Unknown or Not Reported0
Height
Height(cm)Intervention Group
Mean99.3 ± 5.0243
08

Study locations

1 site
  • University of North Florida
    Jacksonville, Florida 32224, United States
09

References and documents

Publications

  • Cesar GM, Mochida LY, Flanagan K, McDonald K, Xu J, Depto-Hoffman D, Aceros J. Stand-on ride-on power mobility devices for children with cerebral palsy: pilot study protocol for waitlist-control pre-post biomechanical changes. Front Pediatr. 2026 Mar 12;14:1761608. doi: 10.3389/fped.2026.1761608. eCollection 2026. PubMed 41908530 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Further discussion is needed given vulnerable population.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Dec 2025, 18 months.

Results were first posted in Aug 2026, 7 months after primary completion.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 18 months is above that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2024
First posted
Jun 12, 2024
StartActual
Jun 1, 2024
Primary completionActual
Dec 31, 2025
CompletionActual
Jul 31, 2026
Results first posted
Aug 28, 2026
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06455930
Lead sponsor
University of North Florida
Responsible party
Guilherme M Cesar (Assistant Professor, University of North Florida) — Principal investigator
First posted
Jun 12, 2024
Start date
Jun 1, 2024
Primary completion
Dec 31, 2025
Completion
Jul 31, 2026
Results posted
Aug 28, 2026
Last update
Sep 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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