- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07573891
Combined Effect of FES And FCT in Cerebral Palsy
Combined Effect of Functional Electrical Stimulation and Functional Circuit Training on Postural Stability, Balance, And Functional Mobility in Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, MS
- Phone Number: +923324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54500
- Gulab Devi Hospital Lahore
-
Contact:
- Javeria Ghazal, MS
- Phone Number: +923335154664
- Email: javeria.ghazal@riphah.edu.pk
-
Principal Investigator:
- Tehreem Fatima, MsNMPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of cerebral palsy
- GMFSC level 1 to 3
- Ability to follow simple instructions
- Ability to follow physical therapy commands
Exclusion Criteria:
• Severe cognitive impairment
- Uncontrolled seizures
- Recent lower limb surgery
- Botulinum injections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
Strengthening exercise 10 min Balance and Coordination 10 min Core strengthening 10 min 3 sessions per week on alternate days for 8 weeks
|
|
Experimental: Functional Electrical Stimulation and Functional Circuit Training
|
Strengthening exercise 10 min Balance and Coordination 10 min Core strengthening 10 min Functional Circuit Training 10 min 3 sessions per week on alternate days for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Pediatric Quality of Life Inventory for quality of life
Time Frame: 8th week
|
The Pediatric Quality of Life Inventory Measurement Model was created as a modular approach to measuring pediatric Health Related Quality of Life, integrating the relative benefits of generic and disease-specific approaches.
|
8th week
|
|
Gross motor function measure for functional level
Time Frame: 8th week
|
Children with cerebral palsy can have their gross motor function measured by rehabilitation specialists using the Gross Motor Function Measure. The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping |
8th week
|
|
Pediatric balance scale to measure balance
Time Frame: 8th week
|
It is developed as a balance measure for children. the Pediatric Balance Scale (PBS) is a variation of the Berg Balance scale. Administering the PBS measure is quick and simple, and it doesn't require any additional equipment. Balance functions in school-age children with mild-to-moderate motor impairments and children with cerebral palsy have been assessed using the PBS. The activities vary from standing on one leg to timed seated balance. Scoring of the PBS ranges from 0 points (lowest function) to 4 points (highest function) for each item. The maximum total score is 56 points |
8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javeria Ghazal, MS, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- REC/RCR & AHS/24/0299
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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