- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07712315
Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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KPK
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Mansehra, KPK, Pakistan, 25000
- Ibadat International University, Islamabad
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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Active Comparator: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM-88)
Time Frame: 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.
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10-Meter Walk Test (10MWT)
Time Frame: 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
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Timed Up and Go (TUG) test
Time Frame: 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:
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Assessment was performed at baseline and after 6 weeks of intervention.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIUI/RERC/ADT/2026/01/215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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