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Clinical Trials/NCT06407921
NCT06407921
Recruiting
Not Applicable

Comparative Effects of Whole Body Vibration and BOSU Ball on Balance and Functional Mobility in Children With Spastic Cerebral Palsy

Riphah International University1 site in 1 country32 target enrollmentJune 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spastic Cerebral Palsy
Sponsor
Riphah International University
Enrollment
32
Locations
1
Primary Endpoint
Timed Up & Go test
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Cerebral palsy is a non-progressive neurodevelopmental disorder, also known as littles disease.The most common cause of physical and mental disabilities in the pediatric population. Cerebral means brain and palsy means weakness or problems in muscles. Spastic cerebral palsy is the common type of cerebral palsy characterized by spasticity or high muscle tone, results in stiffness etc.

This will be a randomized clinical trial, data will be collected from Sehat medical complex Lahore. Study will be conducted on 62 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to Walk at least 10m with or without walking aids, able to understand command will be included. Those diplegic spastic CP who have orthopedic intervention/surgery, botulinum toxin injection within past six months, epilepsy and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded.

Detailed Description

Group A: whole body vibration therapy group This group will be provided with whole body vibration therapy in spastic cerebral palsy children. Exercise will be conducted 3 times a week for 8 weeks. Pre and post session functional mobility and balance will be measured by pediatric balance scale and time up and go test. Along routine physical therapy such as stretching exercise of achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, and wrist flexors, pronators, and ulnar deviator etc. Group B: BOSU ball training group This group will be provided with both sides up ball BOSU training in spastic cerebral palsy children. Exercise will be conducted 3 times a week for 8 weeks. Pre and post session functional mobility and balance will be measured by pediatric balance scale and time up and go test. Along routine physical therapy such as stretching exercise of achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, and wrist flexors, pronators, and ulnar deviator etc.

Registry
clinicaltrials.gov
Start Date
June 28, 2024
End Date
August 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Spastic diplegic CP with GMFCS level I-II
  • Age 6-12 years
  • Able to understand command

Exclusion Criteria

  • Orthopedic surgery within 6 months
  • Botulinum injection
  • Parents refuse to participate
  • Other diseases

Outcomes

Primary Outcomes

Timed Up & Go test

Time Frame: 8 weeks

TUG is used to determine functional mobility.Functional mobility of children will be evaluated through timed get up and go (TUG) test and its results will be recorded. In this test, the duration of standing up from the chair, walking up to 3 m, returning, and sitting on the chair will be measured. It is a very valid and reliable tool 0.97 and 0.99.

Pediatric Balance Scale

Time Frame: 8 weeks

The (PBS) pediatric balance scale, a modification of the Berg Balance Scale, was developed as a balance measure for school-age children with mild-to-moderate motor impairments. It gives good test-retest and interrater reliability when used, ranged from 0.87 to 1.0.

Functional Mobility Scale

Time Frame: 8 weeks

FMS (functional mobility scale) is used to measure functional mobility and its results will be recorded. It has perfect test-retest reliability (κw=0.98-1.00)

Study Sites (1)

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