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Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
virtual reality glasses
The traditional exercise program
Sponsored by
Amr Mohsen Mohamed Abo Khatwa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children will be included in the study if they fulfil the following criteria: A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists. Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS). Their age range from 6 to 12 years. Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques. Exclusion Criteria: Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded: They had a permanent deformity (bony or soft tissue contractures). Children having visual or auditory defects. Current hospitalization for urgent medical reasons. Severe mental retardation. Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey. Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.

Sites / Locations

  • Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group (A)

Group (B)

Arm Description

Group (A) will receive virtual reality in addition to the traditional exercise program.

Group (B) will receive traditional exercise program.

Outcomes

Primary Outcome Measures

GROSS MOTOR PERFORMANCE
we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance. this score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value
BALANCE
we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
June 6, 2023
Sponsor
Amr Mohsen Mohamed Abo Khatwa
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1. Study Identification

Unique Protocol Identification Number
NCT05740020
Brief Title
Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia
Official Title
Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amr Mohsen Mohamed Abo Khatwa

4. Oversight

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

5. Study Description

Brief Summary
This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.
Detailed Description
The current study will be directed to investigate effect of virtual reality on gross motor and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity potentially predispose balance and walking issues of children with bilateral spastic CP . The balance deficits in children with CP are multifactorial. According to the system's model proposed by Woollacott and Shumway-Cook, multiple systems contribute to postural dysfunction in children with CP. Muscle weakness and stiffness of lower limb muscles account for biomechanical constraints and postural malalignment during standing and functional balancing. Virtual reality is one of the novel technology-based approaches to treat balance and motor function in children with CP. It utilizes the interactive simulations created in computer hardware and software, in which the children find opportunities to engage in environments appearing real to them . After reviewing the available previous published studies, it was found that there is no previous study directly compared between the effects of virtual reality and physical therapy in spider cage on gross motor performance and balance with diplegic children CP children. Both therapeutic modalities were found to induce good clinical outcomes when studied separately, so this study will be conducted to examine the effectiveness of virtual reality. The greater demand for physical therapy for Paediatrics' signifies the need for more effective, safer and evident therapeutic modalities. The findings of this study will help both; the therapists and the children to save time, effort and reach the best results in concise times.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Experimental
Arm Description
Group (A) will receive virtual reality in addition to the traditional exercise program.
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
Group (B) will receive traditional exercise program.
Intervention Type
Device
Intervention Name(s)
virtual reality glasses
Intervention Description
A specialized VR glasses will be used and VR games application in spider cage
Intervention Type
Other
Intervention Name(s)
The traditional exercise program
Intervention Description
The selected physical therapy program: Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4). Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5). Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6). Strengthening exercise: aims to improve the functional ability (figure 7). Spider suspension exercise for 30 minutes (figure 8). 5. Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10).
Primary Outcome Measure Information:
Title
GROSS MOTOR PERFORMANCE
Description
we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance. this score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value
Time Frame
3 monthes
Title
BALANCE
Description
we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value
Time Frame
3 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children will be included in the study if they fulfil the following criteria: A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists. Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS). Their age range from 6 to 12 years. Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques. Exclusion Criteria: Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded: They had a permanent deformity (bony or soft tissue contractures). Children having visual or auditory defects. Current hospitalization for urgent medical reasons. Severe mental retardation. Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey. Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Mohsen, bachelor's
Phone
01019161542
Email
Amr201220142016@gmail.com
Facility Information:
Facility Name
Physical Therapy
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Mohsen, bachelor's
Phone
01019161542
Email
Amr201220142016@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia

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