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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Pre (immediately before intervention), Post (3 months post Pre)

Results posted on

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

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

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

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

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

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

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guilherme Cesar

University of North Florida

Phone: +1-904-620-2664

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place