Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia
1 other identifier
interventional
30
1 country
1
Brief Summary
This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
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
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJanuary 18, 2024
January 1, 2024
3 months
February 13, 2023
January 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
GROSS MOTOR PERFORMANCE
we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance. this score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value
3 monthes
BALANCE
we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value
3 monthes
Study Arms (2)
Group (A)
EXPERIMENTALGroup (A) will receive virtual reality in addition to the traditional exercise program.
Group (B)
ACTIVE COMPARATORGroup (B) will receive traditional exercise program.
Interventions
A specialized VR glasses will be used and VR games application in spider cage
The selected physical therapy program: 1. Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4). 2. Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5). 3. Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6). 4. Strengthening exercise: aims to improve the functional ability (figure 7). 5. Spider suspension exercise for 30 minutes (figure 8). 5\. Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10).
Eligibility Criteria
You may qualify if:
- Children will be included in the study if they fulfil the following criteria:
- A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS).
- Their age range from 6 to 12 years.
- Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques.
You may not qualify if:
- Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded:
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Current hospitalization for urgent medical reasons.
- Severe mental retardation.
- Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
- Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physical Therapy
Kafr ash Shaykh, Kafrelsheikh, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- SPONSOR INVESTIGATOR
- PI Title
- bachelor's degree of physical therapy
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 22, 2023
Study Start
April 1, 2023
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
January 18, 2024
Record last verified: 2024-01