Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Primary Endpoint
- Gross motor function
Study Overview
Brief Summary
Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. However, adding extra weight during Whole body vibration for children with cerebral palsy as a means of enhancing the potential effects of Whole body vibration is unknown. Therefore, the aim of this study is to examine the effect of Whole body vibration with weighted vest on trunk control, balance and gross motor function in children with spastic diplegia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Their age will range from 8-12 years, from both sexes.
- •Level II and III of gross motor functional classification system
- •Grade 1 and 1+ spasticity according to the Modified Ashworth Scale
- •Ability to understand and follow simple verbal instruc
Exclusion Criteria
- •Uncontrolled epilepsy.
- •Mental retardation or autistic features.
- •Medication changes that could affect muscle strength or tone
- •Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
- •Structural or fixed soft tissue deformities of the lower and/or upper extremities.
- •Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
- •Botox injection in the lower and/or upper extremities in the past 6 months.
Arms & Interventions
Group I
15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months.
Intervention: physical therapy program (Other)
Group I
15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months.
Intervention: whole body vibration (without extra weight vest) (Other)
Experimental group
15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest.
Intervention: physical therapy program (Other)
Experimental group
15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest.
Intervention: whole body vibration (with weight vest) (Other)
Outcomes
Primary Outcomes
Gross motor function
Time Frame: three months
The Gross motor function measure-88 will be used to assess motor function in 88 items across five dimensions: (a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. dimensions D and E will be assessed in the current study The assessment of each item will be conducted carefully and scored according to the scale scoring key (scale from 0-3) with total score 100 and higher score represent better performance
Trunk control
Time Frame: three months
The Trunk Control Measurement Scale is used to assess trunk control and consists of static and dynamic sitting balance in children aged 8 to 15 years with spastic CP
balance
Time Frame: three months
Human computer balance system will be used to assess balance to assess center op pressure and limits of stability
Secondary Outcomes
No secondary outcomes reported
Investigators
Amira Mahmoud Abd-elmonem
Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university
Cairo University