Stand-on Ride-on Power Mobility Devices för barn med cerebral pares
Biomekaniska förändringar som ligger till grund för Stand-on Ride-on Power Mobility Devices för barn med cerebral pares
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32224
- University of North Florida
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Center of Pressure Sway Area, Standing
Tidsram: 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. |
Pre (immediately before intervention), Post (3 months post Pre)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Center of Pressure Sway Area, Sit-to-stand
Tidsram: 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. |
Pre (immediately before intervention), Post (3 months post Pre)
|
|
Trunk-pelvis Coupling
Tidsram: 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. |
Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UNFlorida
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Further discussion is needed given vulnerable population.
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