- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05692336
a Comparison Between the Effectiveness of Vestibular and Dual Task on Balance in Diplegic Children
a Comparison Between the Effectiveness of Vestibular Versus Dual Task Training on Balance in Children With Diplegic Cerebral Palsy
the study is carried out to identify If there is any difference between the effectiveness of Vestibular training and Dual task training on balance in children with Diplegic Cerebral Palsy.
so in this study the sample will be divided into two equal groups, each group will recieve only one type of training ( vestibular training or dual task training ) the balance of the diplegic children will be assessed before and after using HUMAC balance system and pediatric balance scale , the results will be compared between both groups and if there is one training is more effective than the other , it will be recommended most in the future treatment program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A comparative experimental design was used. Children participating in this study were assigned into two equal groups, Thirty four children with diplegic Cerebral Palsy of both genders who have balance problems were selected to join this study with the following criteria:
- all the children diagnosed as diplegic cerebral palsy.
- Their age are range from 5 to 10 years old.
- The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
- They are at level I OR II on Gross Motor Function Classification System .
- All the children were able to follow verbal command and instructions.
And Children were excluded in the presence of the following:
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months..
all the children will be assigned in one of two groups ( vestibular training group and dual task group ) the training will be continue for definite period of time , and the balance abilities for the children in each group will be assessed before and after the treatment completely ended and the result will be compared to conclude which group benefit more and have a greater balance improvement and the treatment that causes a greater improvement will be more recommended in the future physical therapy plan for treatment of diplegic cerebral palsied children.
the balance is assessed using HUMAC balance system and pediatric balance scale .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: amira A mahmoud, bachelor
- Phone Number: +201015039297
- Email: ashrafamira74@gmail.com
Study Locations
-
-
-
Giza, Egypt
- Recruiting
- Faculty of Physical Therapy Cairo University
-
Contact:
- amira A mahmoud
- Phone Number: +201015039297
- Email: ashrafamira74@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinical diagnosis of diplegic cerebral palsy .
- age range : from 5 to 10 years old.
- The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
- They are at level I OR II on Gross Motor Function Classification System .
- All the children were able to follow verbal command and instructions.
Exclusion Criteria:
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months
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: vestibular training
balance training that focus on vestibular system stimulation like when the eyes are folded while standing on a balance board or walking on swinging boards
|
balance training in the form of vestibular training
|
|
Experimental: dual task training
The children received special balance training in the form of dual-task training performing balance activities as a basic task in conjunction with second task that includes upper limb activity using basketball and long rings shaft or cognitive task like telling a story during balance training .
|
balance training in the form of dual task training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Balance
Time Frame: 2 months of training
|
static balance will be assessed using HUMAC balance system , a comparison of the results between two groups will be carried out , and the more effective treatment program will be more recommended than the other
|
2 months of training
|
|
dynamic balance
Time Frame: 2 months of training
|
dynamic balance will be assessed using pediatric balance scale and a comparison between the results of the two groups will be done to recommend one over the other.
|
2 months of training
|
|
which training will be more beneficial for the diplegic child balance
Time Frame: 2 months
|
after the results of both groups (for static and dynamic balance) are analyzed one treatment will be recommended most (the treatment for the group that has greater balance improvement ).
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: amira A mahmoud, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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/012/003716
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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