Biomechanical Changes Underpinning Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- Center of pressure sway area, standing
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
In this phase of the study, masking cannot be done as all participants will receive the intervention.
Eligibility Criteria
- Ages
- 4 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of spastic diplegia CP, GMFCS level III;
- •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);
- •Able to stand and to walk short distances (at least 10 meters) with or without external assistance;
- •Physician medical clearance to participate; and
- •Exhibit sufficient cooperation and attention so that simple verbal instructions can be followed.
Exclusion Criteria
- •Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening);
- •Inadequate vision to complete study's procedures safely;
- •Serious/unstable cardiac conditions that prevent engagement in the Evaluation Sessions; and
- •Any other factor that might hinder full participation in the study or confound interpretation of the results.
Arms & Interventions
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.
Intervention: Stand-on ride-on power mobility device (Device)
Outcomes
Primary Outcomes
Center of pressure sway area, standing
Time Frame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Measure of balance control during independent standing
Center of Pressure Sway Area, Standing
Time Frame: 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.
Secondary Outcomes
- Trunk-pelvis coupling(Baseline, Pre (3 months post Baseline), Post (3 months post Pre))
- Thigh muscle co-contraction (quadriceps:biceps femoris)(Baseline, Pre (3 months post Baseline), Post (3 months post Pre))
- Center of pressure sway area, sit-to-stand(Baseline, Pre (3 months post Baseline), Post (3 months post Pre))
- Center of Pressure Sway Area, Sit-to-stand(Pre (immediately before intervention), Post (3 months post Pre))
- Trunk-pelvis Coupling(Baseline, Pre (3 months post Baseline), Post (3 months post Pre))
Investigators
Guilherme M Cesar
Assistant Professor
University of North Florida