- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438223
Effect Of Brain Gym Exercises On Balance And Quality Of Life In Children With Spastic Diplegia
Statement of the problem Do brain gym exercises affect balance and quality of life in children with spastic diplegia?
Null hypotheses:
- There will be no significant effect of brain gym exercises on balance in children with spastic diplegia.
- There will be no significant effect of brain gym exercises on quality of life in children with spastic diplegia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hebatallah Mohamed Kamal, Professor
- Phone Number: +201065263619
- Email: heba.kamal@pt.cu.edu.eg
Study Contact Backup
- Name: Maya Galal Abd-Alwahab, Assistant professor
- Phone Number: +201141904589
- Email: maya.galal@pt.cu.edu.eg
Study Locations
-
-
Faculty of Physical Therapy
-
Cairo, Faculty of Physical Therapy, Egypt
- Recruiting
- Faculty of Physical Therapy Cairo University
-
Contact:
- Maya Galal Abd-Alwahab, Assistant professor
- Phone Number: +201141904589
- Email: maya.galal@pt.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1 - Children with spastic diplegia who have balance problems in standing and gait.
2-Degree of spasticity ranges from 1 and 1+, according to modified Ashworth scale (MAS) .
3- The age of children will range from 6 to 8 years old. 4-The height of children will be at least one meter. 5- Children are levels I and II according to GMFCS (Gross Motor Classification System ).
Exclusion Criteria:
- Children with visual or auditory problems.
- Children with intellectual disability.
- Children have been injected with Botox injection or have done surgery in the last 6 months.
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: group A will take conventional physical therapy and brain gym exercises
Group A will take conventional physical therapy for 45 minutes and brain gym exercises for 30 minutes for three months three sessions per week . Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump |
Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midline movements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump
Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump
|
|
Experimental: Group B the control group will take only conventional physical therapy
will take the same conventional physical therapy program for 45 minutes three times per week for three months.
|
Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 3 months
|
Biodex balance system will measure the overall stability index, antero -posterior stability index and medio- lateral stability index, higher score indicate lower stability.
|
3 months
|
|
Quality of life
Time Frame: 3 months
|
Cerebral Palsy Quality Of Life Questionnaire (CPQOL)contains 66 items each uses a 9- point rating scale ( for items The minimum value 1, maximum value 9)and then transformed to a 0 to 100 scale.
As the total score approaches 100 this means better quality of life.
The domains evaluated using it are social well being and acceptance, emotional well-being, function and participation and physical health, access to services, pain and impact of disability, and family health..
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hagar Mohamed Awaad, Assistant lecturer, Cairo University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC\012\006105
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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