- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679779
Virtual Reality in Children With Hemiparesis
February 19, 2021 updated by: Ahmed Ebrahem Fayed, Cairo University
Effect of Virtual Reality on Selective Motor Control and Upper Limb Functions in Children With Hemiparesis: A Pilot Study
children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12662
- Egypt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: control group
receive occupational therapy program
|
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.
|
|
Experimental: study group
receive wii virtual reality
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Selective voluntary motor control of upper extremity
Time Frame: 6 weeks
|
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
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength
Time Frame: 6 weeks
|
it will be assessed by hand held dynamometer
|
6 weeks
|
|
- Upper limb function
Time Frame: 6 weeks
|
it will be assessed by Bruinink-Oseretsky test for motor proficiency subset 7 of upper limb coordination
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: hoda eltalawy, professor, Cairo University
- Study Director: shorouk elshennawy, professor, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 15, 2021
Study Registration Dates
First Submitted
December 17, 2020
First Submitted That Met QC Criteria
December 17, 2020
First Posted (Actual)
December 22, 2020
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 19, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Virtual Reality
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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