- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244159
Effects of Dynamic Surface Exercise Training in Children With Diplegic Cerebral Palsy
Effects of Dynamic Surface Exercise Training on Functional Mobility, Balance and Coordination in Children With Diplegic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times).
This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set. On floor, standing: throwing and catching the ball from different direction, 10 times each side, 1 set Gross motor function measure-88 and pediatric balance scale and time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Hafiza Iram Batool
-
Contact:
- Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 5 and 8 years of both genders
- Classification as level III and IV on the Gross Motor Function Classification system (GMFCS)
Exclusion Criteria:
• Any orthopedic surgery or botulinum toxin injection in the past 6 months.
- Refusal by the parents to participate.
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 |
|---|---|
|
Active Comparator: Group A
This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks.
For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) .
The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions)
|
This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks.
For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) .
The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions).
Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times.
|
|
Active Comparator: Group B
This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks.
Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day.
On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set
|
This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks.
Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM)
Time Frame: baseline, 1st week and 6th week
|
Balance Scale (PBS) will be the outcome measures use in this trial.
GMFM-88 has excellent relative reliability of excellent (Intraclass correlation coefficient (ICC) = 0.952-1.000)
|
baseline, 1st week and 6th week
|
|
Pediatric Berg Balance Scale
Time Frame: baseline, 1st week and 6th week
|
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
|
baseline, 1st week and 6th week
|
|
Time up and go test
Time Frame: baseline, 1st week and 6th week
|
Reliability of TUG test was high, with ICC of 0.99 for within-session reliability and 0.99 for test-retest reliability
|
baseline, 1st week and 6th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Iram Batool, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/HAFIZA IRAM BATOOL
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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