Whole Body Vibration and BOSU Ball in Spastic Cerebral Palsy

NCT06407921 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/07100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Spastic Cerebral Palsy

Keywords

cerebral palsy; WBVT; bosu ball; functional mobility; balance

Outcome Measures

Primary Outcomes (3)

• Pediatric Balance Scale

  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

  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

  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

Study Arms (2)

Whole Body Vibration Therapy

EXPERIMENTAL

This group will receive Whole Body Vibration Therapy

Device: Whole Body Vibration

BOSU ball therapy

EXPERIMENTAL

This group will receive BOSU ball therapy

Device: BOSU ball

Interventions

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

Whole Body Vibration Therapy

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

BOSU ball therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.

  PMID: 25724849 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hafsa Imtiaz, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant's will get separate treatment protocols and possible efforts will be put to msk the both group about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. group A will only receive Whole Body Vibration therapy and group B will only receive BOSU ball.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: June 28, 2024
• Primary Completion: August 8, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)