Stand-on Ride-on elektrische mobiliteitshulpmiddelen voor kinderen met hersenverlamming
Biomechanische veranderingen die ten grondslag liggen aan stand-on ride-on elektrische mobiliteitshulpmiddelen voor kinderen met hersenverlamming
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- University of North Florida
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Center of Pressure Sway Area, Standing
Tijdsspanne: Pre (immediately before intervention), Post (3 months post Pre)
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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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Center of Pressure Sway Area, Sit-to-stand
Tijdsspanne: 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
Tijdsspanne: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
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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)
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Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UNFlorida
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Further discussion is needed given vulnerable population.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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