Whole Body Vibration and BOSU Ball in Spastic Cerebral Palsy

Spastic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407921
• Other study ID #: REC/RCR&AHS/HAFSAIMTIAZ
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: July 4, 2024

Study information

• Verified date: May 2024
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 9233224390125
• Email: Imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: July 4, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spastic Cerebral Palsy

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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 (?w=0.98-1.00)	8 weeks