Stående kjøre-på-kraftmobilitetsenheter for barn med cerebral parese
Biomekaniske endringer som ligger til grunn for stå-på-kjørende kraftmobilitetsenheter for barn med cerebral parese
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Jacksonville, Florida, Forente stater, 32224
- University of North Florida
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Center of Pressure Sway Area, Standing
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Center of Pressure Sway Area, Sit-to-stand
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UNFlorida
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Further discussion is needed given vulnerable population.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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