Trial Outcomes & Findings for Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy (NCT NCT06455930)
NCT ID: NCT06455930
Last Updated: 2026-08-28
Results Overview
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.
COMPLETED
NA
10 participants
Pre (immediately before intervention), Post (3 months post Pre)
2026-08-28
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.
Ten participants with cerebral palsy were enrolled in the study following eligibility screening. One participant did not return for post-intervention assessment, lost to follow-up.
Participant milestones
| Measure |
Intervention Group
Children with cerebral palsy who participated in the stand-on powered mobility device intervention and were included in outcome analyses (n=10).
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Baseline Assessment
|
10
|
|
Overall Study
Pre-Intervention Assessment
|
10
|
|
Overall Study
Post-Intervention Assessment
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intervention Group
Children with cerebral palsy who participated in the stand-on powered mobility device intervention and were included in outcome analyses (n=10).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Intervention Group
n=10 Participants
Children with cerebral palsy who participated in the stand-on powered mobility device intervention and were included in outcome analyses (n=10).
|
|---|---|
|
Age, Continuous
|
4.8 Years
STANDARD_DEVIATION 0.9189 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
|
Height
|
99.3 cm
STANDARD_DEVIATION 5.0243 • n=31 Participants
|
PRIMARY outcome
Timeframe: Pre (immediately before intervention), Post (3 months post Pre)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.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
Children with cerebral palsy who participated in the stand-on powered mobility device intervention and were included in outcome analyses (n=10).
|
|---|---|
|
Center of Pressure Sway Area, Standing
Pre-Intervention COP Ellipse Area
|
1670.171 mm^2
Interval 1122.309 to 2022.642
|
|
Center of Pressure Sway Area, Standing
Post-Intervention COP Ellipse Area
|
521.777 mm^2
Interval 263.567 to 1830.514
|
SECONDARY outcome
Timeframe: Pre (immediately before intervention), Post (3 months post Pre)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.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
Children with cerebral palsy who participated in the stand-on powered mobility device intervention and were included in outcome analyses (n=10).
|
|---|---|
|
Center of Pressure Sway Area, Sit-to-stand
Pre-Intervention COP Ellipse Area
|
2186.212 mm^2
Interval 1469.301 to 2788.919
|
|
Center of Pressure Sway Area, Sit-to-stand
Post-Intervention COP Ellipse Area
|
2528.908 mm^2
Interval 851.538 to 3852.605
|
SECONDARY outcome
Timeframe: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)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.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
Children with cerebral palsy who participated in the stand-on powered mobility device intervention and were included in outcome analyses (n=10).
|
|---|---|
|
Trunk-pelvis Coupling
Pre-Intervention Coupling Angle
|
120.805 Degrees
Interval 103.137 to 138.03
|
|
Trunk-pelvis Coupling
Post-Intervention Coupling Angle
|
110.798 Degrees
Interval 107.562 to 131.337
|
Adverse Events
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place