Back to resultsVirtual Reality in Children With Hemiparesis
Primary Purpose
Physical Disability
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
designed occupational therapy program
Wii virtual reality games
Sponsored by
About this trial
This is an interventional treatment trial for Physical Disability focused on measuring cerebral palsy, selective motor control, upper limb coordination, virtual reality
Eligibility Criteria
Inclusion Criteria:
- - Age between 7 and 11 years
- spasticity grade of 1+ or 2 on MAS
- level I and II on GMFCS
- level II and III on MACS
- Being able to cooperate and being motivated
Exclusion Criteria:
- visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
- Structural or fixed soft tissue deformities in the affected upper extremity
Sites / Locations
- Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
control group
study group
Arm Description
receive occupational therapy program
receive wii virtual reality
Outcomes
Primary Outcome Measures
Selective voluntary motor control of upper extremity
Test of Arm Selective Control will be used to assess selective voluntary motor control of upper extremityIt was developed to quantify the extent to which children with cerebral palsy have selective voluntary motor control. It will be used to assess movement of shoulder, elbow, forearm, wrist, finger and thumb by using simple tools for grasp items from two starting sitting positions
Secondary Outcome Measures
Hand grip strength
it will be assessed by hand held dynamometer
- Upper limb function
it will be assessed by Bruinink-Oseretsky test for motor proficiency subset 7 of upper limb coordination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04679779
Brief Title
Virtual Reality in Children With Hemiparesis
Official Title
Effect of Virtual Reality on Selective Motor Control and Upper Limb Functions in Children With Hemiparesis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance
Detailed Description
Twenty volunteer children diagnosed with hemiparetic cerebral palsy will be recruited from national institute of neuromotor system. they will be randomly assigned to intervention and control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability
Keywords
cerebral palsy, selective motor control, upper limb coordination, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control grouprecivedvDesigned occupational therapy programe including Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.
• study group will recieve Wii virtual reality games
Bowling
Frisbee
Basketball
Boxing
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Experimental
Arm Description
receive occupational therapy program
Arm Title
study group
Arm Type
Experimental
Arm Description
receive wii virtual reality
Intervention Type
Other
Intervention Name(s)
designed occupational therapy program
Intervention Description
Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.
Intervention Type
Other
Intervention Name(s)
Wii virtual reality games
Intervention Description
Bowling
Frisbee
Basketball
Boxing
Primary Outcome Measure Information:
Title
Selective voluntary motor control of upper extremity
Description
Test of Arm Selective Control will be used to assess selective voluntary motor control of upper extremityIt was developed to quantify the extent to which children with cerebral palsy have selective voluntary motor control. It will be used to assess movement of shoulder, elbow, forearm, wrist, finger and thumb by using simple tools for grasp items from two starting sitting positions
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hand grip strength
Description
it will be assessed by hand held dynamometer
Time Frame
6 weeks
Title
- Upper limb function
Description
it will be assessed by Bruinink-Oseretsky test for motor proficiency subset 7 of upper limb coordination
Time Frame
6 weeks
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 between 7 and 11 years
spasticity grade of 1+ or 2 on MAS
level I and II on GMFCS
level II and III on MACS
Being able to cooperate and being motivated
Exclusion Criteria:
visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
Structural or fixed soft tissue deformities in the affected upper extremity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hoda eltalawy, professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
shorouk elshennawy, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
amira mahmoud, phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Egypt
City
Giza
ZIP/Postal Code
12662
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality in Children With Hemiparesis
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