Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
1 other identifier
interventional
75
1 country
2
Brief Summary
Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 19, 2022
January 1, 2022
3 months
June 19, 2022
July 14, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
6 month
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.
6 month
Study Arms (3)
children treated by the traditional physical therapy program based on Neurodevelopmental technique
EXPERIMENTALTwenty-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
children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
EXPERIMENTALtwenty-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.
children treated by Balance Beam for 15 min besides the traditional physical therapy program
EXPERIMENTALTwenty-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).
Interventions
children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
Physical Therapy
Cairo, Egypt
Physical Therapy
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Pediatrics department, Faculty of Physical Therapy, Cairo University
Study Record Dates
First Submitted
June 19, 2022
First Posted
July 19, 2022
Study Start
August 1, 2022
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
July 19, 2022
Record last verified: 2022-01