- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07712315
Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
KPK
-
Mansehra, KPK, Pakistan, 25000
- Ibadat International University, Islamabad
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
• Participants with age limit of 6-12 years
- Diagnosed cases of Spastic Diplegic Cerebral Palsy by Pediatric neurologist
- Both genders (male/female)
- Participants with GMFCS Level I-III
- Participants with Grade I spasticity, Modified Ashworth Scale (MAS) • Participants able to understand and follow basic commands.
Exclusion Criteria:
• Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past six months
- Children with any surgical procedure of the spine or lower limbs or Botox treatment in the last 6 months
- Children with any visual or hearing impairment
- Children having any fixed deformity, contracture or fracture limiting participation in therapy
- Patients having VP shunt
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental Group A received Vestibular Stimulation along with Conventional therapy.
Participants in this group received Vestibular Stimulation along with Conventional therapy.
|
Experimental Group A received Vestibular Stimulation along with Conventional therapy.
Vestibular stimulation included Multi-directional swinging , Trampoline jumps , Rocking movement , Gaze stabilization exercises , Visual pursuit exercises , Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
|
|
Actieve vergelijker: Control Group B received Conventional physiotherapy alone.
Participants in this group received Conventional physiotherapy alone
|
Control Group B received Conventional physiotherapy alone which includes Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gross Motor Function Measure (GMFM-88)
Tijdsspanne: Assessment was performed at baseline and after 6 weeks of intervention.
|
Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where:
Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions. |
Assessment was performed at baseline and after 6 weeks of intervention.
|
|
10-Meter Walk Test (10MWT)
Tijdsspanne: Assessment was performed at baseline and after 6 weeks of intervention
|
The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy.
The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section.
The time taken to reach the midpoint of the 10 m walk will be recorded.
|
Assessment was performed at baseline and after 6 weeks of intervention
|
|
Timed Up and Go (TUG) test
Tijdsspanne: Assessment was performed at baseline and after 6 weeks of intervention.
|
Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow:
|
Assessment was performed at baseline and after 6 weeks of intervention.
|
Medewerkers en onderzoekers
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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIUI/RERC/ADT/2026/01/215
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .