Whole Body Vibration and BOSU Ball in Spastic Cerebral Palsy

July 28, 2024 updated by: Riphah International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hafsa Imtiaz, MS*

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

  • Child

Accepts Healthy Volunteers

No

Description

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
  • Epilepsy
  • Parents refuse to participate
  • Other diseases

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole Body Vibration Therapy
This group will receive Whole Body Vibration Therapy
Device: Whole Body Vibration
On vibration plate pate child will do kneeling, and one leg standing, standing horizontally or vertically. Along routine physical therapy such as stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, elbow and wrist flexors, pronators, and ulnar deviators, each stretch will be given for 30 seconds with 3 repetitions.Strength training to hip flexor, knee extensor, and ankle dorsiflexors for 15 minutes 3 times a week for 8 weeks. Session will be of 30 minutes
Experimental: BOSU ball therapy
This group will receive BOSU ball therapy
Device: BOSU ball
Exercises such as (1) standing on a BOSU ball while throwing and catching a ball (2) 1-legged standing (affected leg) on the BOSU ball while throwing and catching a ball with therapist support; and (3) small jumps on the BOSU ball. Three sets of 6 repetitions for each exercise will be perform every 2 weeks up to a maximum of 10 repetitions if the participants were still able to perform the training easily. Total dose of balance training in 1 session will be 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Hafsa Imtiaz, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 28, 2024

Primary Completion (Estimated)

August 8, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/07100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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