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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05692336
Other study ID # P.T.REC/012/003716
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2022
Est. completion date April 30, 2023

Study information

Verified date January 2023
Source Cairo University
Contact amira A mahmoud, bachelor
Phone +201015039297
Email ashrafamira74@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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: 1. all the children diagnosed as diplegic cerebral palsy. 2. Their age are range from 5 to 10 years old. 3. The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013). 4. They are at level I OR II on Gross Motor Function Classification System . 5. All the children were able to follow verbal command and instructions. And Children were excluded in the presence of the following: 1. Children that suffer from epilepsy. 2. Severe visual and auditory problems. 3. Structural or fixed soft tissue deformities of Lower extremities. 4. Severe mental retardation. 5. 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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date April 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria: 1. clinical diagnosis of diplegic cerebral palsy . 2. age range : from 5 to 10 years old. 3. The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013). 4. They are at level I OR II on Gross Motor Function Classification System . 5. All the children were able to follow verbal command and instructions. Exclusion Criteria: 1. Children that suffer from epilepsy. 2. Severe visual and auditory problems. 3. Structural or fixed soft tissue deformities of Lower extremities. 4. Severe mental retardation. 5. Botox injection in the lower extremity in the past 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
vestibular training
balance training in the form of vestibular training
dual task training
balance training in the form of dual task training

Locations

Country Name City State
Egypt Faculty of Physical Therapy Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Static Balance 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
Primary dynamic balance 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
Primary which training will be more beneficial for the diplegic child balance 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
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