search
Back to results

a Comparison Between the Effectiveness of Vestibular and Dual Task on Balance in Diplegic Children

Primary Purpose

Diplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vestibular training
dual task training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diplegic Cerebral Palsy

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

vestibular training

dual task training

Arm Description

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

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 .

Outcomes

Primary Outcome Measures

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
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.
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 ).

Secondary Outcome Measures

Full Information

First Posted
December 22, 2022
Last Updated
January 18, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05692336
Brief Title
a Comparison Between the Effectiveness of Vestibular and Dual Task on Balance in Diplegic Children
Official Title
a Comparison Between the Effectiveness of Vestibular Versus Dual Task Training on Balance in Children With Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vestibular training
Arm Type
Experimental
Arm Description
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
Arm Title
dual task training
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
vestibular training
Intervention Description
balance training in the form of vestibular training
Intervention Type
Other
Intervention Name(s)
dual task training
Intervention Description
balance training in the form of dual task training
Primary Outcome Measure Information:
Title
Static Balance
Description
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
Time Frame
2 months of training
Title
dynamic balance
Description
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.
Time Frame
2 months of training
Title
which training will be more beneficial for the diplegic child balance
Description
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 ).
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amira A mahmoud, bachelor
Phone
+201015039297
Email
ashrafamira74@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amira A mahmoud
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amira A mahmoud
Phone
+201015039297
Email
ashrafamira74@gmail.com

12. IPD Sharing Statement

Learn more about this trial

a Comparison Between the Effectiveness of Vestibular and Dual Task on Balance in Diplegic Children

We'll reach out to this number within 24 hrs