Back to resultsVirtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
Primary Purpose
Balance Problems in Spastic Hemiplegic Children, Walking Performance in Spastic Hemiplegic Children
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Balance Problems in Spastic Hemiplegic Children
Eligibility Criteria
Inclusion Criteria:
- Age ranges from 7 to 11 years old, from both genders.
- Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
- They were able to stand and walk.
- Gross motor function measure scale GMFM (level I &II). (Russell et al. ,2013).
- Children with good mentality to understand the evaluation steps.
Exclusion Criteria:
- Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
- Children who have any spinal deformities.
- Children with severe muscle contracture.
Sites / Locations
- Physical Therapy
- Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
children treated by the traditional physical therapy program based on Neurodevelopmental technique
children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
children treated by Balance Beam for 15 min besides the traditional physical therapy program
Arm Description
Twenty-five cerebral palsied hemiplegic children will be treated by the traditional physical therapy program ( balance board, single limb support, standing with throwing ball ) based on Neurodevelopmental technique for 6 month
twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by Virtual reality with use of the HMD helmet allows users to perceive a 3D stereoscopic images that enable participants to interact with different balance games as football Soccer, football heading (known as Soccer Heading), the tight rope walks and the Penguin slide game.
Twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by standing and walking in balance beam by differentiate levels of walking balance proficiency as varying widths of beam and walking in different direction (forward or backward).
Outcomes
Primary Outcome Measures
Balance it will be assist by HUMAC Balance Assessment system
Evaluation materials that used in assist balance :
HUMAC Balance Assessment system consists of:
1- The force platform 2- The HUMAC CD holding the operating program This test will be use assess the sensory integration of balance and postural control in the conditions of eyes open and eyes closed from standing, lasts for 30 second and the test was repeated for three times and the mean value is calculated from the result of each trial which appears in the form of percent of stability in each trial
Walking ability
Evaluation materials
Six Minute Walk Test (6MWT) it is a valid and reliable instrumentation using to asses walking capacity The child of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway, after the test, measured walking capacity exercise (BP, HR and SpO2) were re-measured.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05463718
Brief Title
Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
Official Title
Virtual Reality Versus Balance Beam on Walking Performance in Children With Spastic Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (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
Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?
Detailed Description
To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.
To compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.
To compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance Problems in Spastic Hemiplegic Children, Walking Performance in Spastic Hemiplegic Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children treated by the traditional physical therapy program based on Neurodevelopmental technique
Arm Type
Experimental
Arm Description
Twenty-five cerebral palsied hemiplegic children will be treated by the traditional physical therapy program ( balance board, single limb support, standing with throwing ball ) based on Neurodevelopmental technique for 6 month
Arm Title
children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
Arm Type
Experimental
Arm Description
twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by Virtual reality with use of the HMD helmet allows users to perceive a 3D stereoscopic images that enable participants to interact with different balance games as football Soccer, football heading (known as Soccer Heading), the tight rope walks and the Penguin slide game.
Arm Title
children treated by Balance Beam for 15 min besides the traditional physical therapy program
Arm Type
Experimental
Arm Description
Twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by standing and walking in balance beam by differentiate levels of walking balance proficiency as varying widths of beam and walking in different direction (forward or backward).
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
Primary Outcome Measure Information:
Title
Balance it will be assist by HUMAC Balance Assessment system
Description
Evaluation materials that used in assist balance :
HUMAC Balance Assessment system consists of:
1- The force platform 2- The HUMAC CD holding the operating program This test will be use assess the sensory integration of balance and postural control in the conditions of eyes open and eyes closed from standing, lasts for 30 second and the test was repeated for three times and the mean value is calculated from the result of each trial which appears in the form of percent of stability in each trial
Time Frame
6 month
Title
Walking ability
Description
Evaluation materials
Six Minute Walk Test (6MWT) it is a valid and reliable instrumentation using to asses walking capacity The child of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway, after the test, measured walking capacity exercise (BP, HR and SpO2) were re-measured.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ranges from 7 to 11 years old, from both genders.
Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
They were able to stand and walk.
Gross motor function measure scale GMFM (level I &II). (Russell et al. ,2013).
Children with good mentality to understand the evaluation steps.
Exclusion Criteria:
Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
Children who have any spinal deformities.
Children with severe muscle contracture.
Facility Information:
Facility Name
Physical Therapy
City
Cairo
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Physical Therapy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
physical therapy, doctoral
Phone
02 37617691
Email
un.grad@pt.cu.edu.eg
12. IPD Sharing Statement
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Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
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