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NCT Number: NCT06407921

Whole Body Vibration and BOSU Ball in 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 30 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 both male nd female, able to understand command will be included. Those diplegic spastic CP who have orthopedic intervention/surgery, botulinum toxin injection within past six months, or medical problems such as pneumonia that prevented children from participating in exercises will be excluded.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spastic diplegic CP with GMFCS level I-II
  • Age 6-12 years
  • Both male and female.
  • Able to understand command

Exclusion criteria

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

Treatment and study plan

Whole Body Vibration

Device

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

BOSU ball

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 9, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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