Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
Primary Purpose
Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
designed physical therapy program in addition to program of virtual reality.
designed physical therapy program in addition to program of mirror therapy.
Sponsored by
About this trial
This is an interventional treatment trial for Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Their ages will range from 6 to 10 years old.
- The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
- They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
- Their heights will be one meter or more.
- They will be able to follow the verbal commands or instructions.
Exclusion Criteria:
- Severe visual or auditory problems.
- Epilepsy.
- History of surgical interference in lower limbs.
- Botulinum toxin injections of the lower limbs during the previous six
Sites / Locations
- Emad EldinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group A
group B
Arm Description
will receive a designed physical therapy program in addition to program of virtual reality
will receive a designed physical therapy program in addition to program of mirror therapy.
Outcomes
Primary Outcome Measures
Biodex balance system
The Biodex balance System to measures postural stability under dynamic stress.
Hand held dynamometer
The hand held dynamometry to measure muscle strength of non-disabled children
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05331703
Brief Title
Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
Official Title
Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Anticipated)
Primary Completion Date
March 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
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
Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).
Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
will receive a designed physical therapy program in addition to program of virtual reality
Arm Title
group B
Arm Type
Experimental
Arm Description
will receive a designed physical therapy program in addition to program of mirror therapy.
Intervention Type
Other
Intervention Name(s)
designed physical therapy program in addition to program of virtual reality.
Intervention Description
physical therapy program in addition to program of virtual reality.
Intervention Type
Other
Intervention Name(s)
designed physical therapy program in addition to program of mirror therapy.
Intervention Description
physical therapy program in addition to program of mirror therapy.
Primary Outcome Measure Information:
Title
Biodex balance system
Description
The Biodex balance System to measures postural stability under dynamic stress.
Time Frame
3 months
Title
Hand held dynamometer
Description
The hand held dynamometry to measure muscle strength of non-disabled children
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Their ages will range from 6 to 10 years old.
The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
Their heights will be one meter or more.
They will be able to follow the verbal commands or instructions.
Exclusion Criteria:
Severe visual or auditory problems.
Epilepsy.
History of surgical interference in lower limbs.
Botulinum toxin injections of the lower limbs during the previous six
Facility Information:
Facility Name
Emad Eldin
City
Cairo
State/Province
October
ZIP/Postal Code
8124
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emad mohamed, phd
Phone
01146808839
Email
omdamohamed9111@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
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