- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995952
Comparsion of Gross Motor Task Training and Trunk Trageted Training
Comparison Of Gross Motor Task Training And Trunk Targeted Training On Balance, Range Of Motion And Community Participation In Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria male & female.
- GMFCS III V
- Age 8to12 years
- Diplegic cerebral palsy
- Hypoxic brain injury
- Diagnosed with a gross motor delay by the pediatrician.
Exclusion Criteria:
- Children having a cognitive or psychiatric disorder.
- Children with known congenital limb anomaly
- Children with some chromosomal defect
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gross motor training activity
Gross motor training activity It includes training of motor components of child grossly
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Gross motor training activity (1 hour session, 3 times a week for 3 months).
Pre ad post assessments will be taken.
The Gross motor training activity will include: sit to stand, step-ups and walking.
The sit to stand will be performed for 20 minutes involving 20 repetitions.
We will progress from high seat sit to stand to low seat sit to stand.
The step up will progress initially from a bench having low height to high height and then to stepping of stairs for 20 minutes involving 30 repetitions.
The walking will occur from 3m walk and then increasing the distance
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Experimental: Trunk targeted training
In this training group the particpiants were given the exercises that were focused the truck muscles
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Trunk targeted training (1hour session, 3 times a week for 3 months). Pre and Post assessment will be evaluated. The trunk targeted training will include: weight supported treadmill walk, specific trunk exercises with vibration therapy and reaching forward to the limits of stability. Specific trunk exercises will involve stride sitting to standing, sitting on a roll and moving the roll in diagonal and forward backward directions along with giving vibrational therapy on wobble board, side sitting. This activity will be performed for 30 minutes with 30 repetitions. Reaching forward to the limits of stability exercises will be performed. Asking the children to hold objects from right hand while reaching for an object on left side and vice versa. This will be performed for 20 minutes having 20 repetitions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional mobility assessment
Time Frame: 10 minutes
|
It classifies the functional mobility of children between ages 4-18 years of age with cerebral palsy.
The scale can be used to classify children's functional mobility, document change over time in the same child and to document change.
The FMS rates walking ability at three specific distances, 5, 50 and 500 meters, (or 5, 50, 500 yards).
This represents the child's mobility in the home, at school and in the community setting
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10 minutes
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Pediatric Berg Balance Scale
Time Frame: 20 minutes
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The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children and children with cerebral palsy.
The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
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20 minutes
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Goniometer
Time Frame: 10 minutes
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This is an instrument which is used to measure the range of motion
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10 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Prof S Shakil Ur Rehman, Phd, Riphah International University
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
- RiphahIU maryam
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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