Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Power Mobility Device, Balance, Muscle activity, Mobility
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.
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).
Sponsors
University of North Florida
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
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.
Intervention model description
In this foundational study, only one group will participate and receive the intervention.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center of Pressure Sway Area, Standing | 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
| Measure | Time frame | Description |
|---|---|---|
| Center of Pressure Sway Area, Sit-to-stand | 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. |
| Trunk-pelvis Coupling | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 4.8 Years STANDARD_DEVIATION 0.9189 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 99.3 cm STANDARD_DEVIATION 5.0243 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
None listed