Whole Body Vibration for Hemiparetic Cerebral Palsy

Effect of Whole Body Vibration on Upper Limb Range of Motion and Strength in Children With Hemiparetic Cerebral Palsy

This study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors.

Study Overview

• Status: Recruiting
• Conditions: Physical Therapy
• Intervention / Treatment: Procedure: Physical therapy exercises.

Detailed Description

Studies show efficacy of whole body vibration in reducing spasticity, improving strength, balance, ankle dorsiflexion angle and gait parameters in post stroke and spinal cord injury patients improving posture and balance in patients with Parkinson's disease and multiple sclerosis. Although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy.

Few Studies Have Shown improvement in children with cerebral palsy: spasticity decrease as measured by isokinetic dynamometer. Strength of muscles increase as measured by hand held dynamometer. Motor function increase as measured by Gross Motor Function Measure and Gross Motor Function Classification Scale. Increase of the activation and the co- activation of biceps and triceps. Vibrations increase bone mass and muscle strength in upper limbs.

Vibration therapy decreases spasticity and improve motor performance in children with cerebral palsy. Reduce flexors spasticity and improve functions in the rehabilitation of upper limb spasticity. Focal muscle vibration on triceps brachii muscle can reduce the spasticity for both elbow and wrist joint muscles.

So in this study, the investigators are trying to implement an additional rehabilitation method for upper limbs in hemiparetic children to improve their upper limb range of motion and strength which will reflect an improvement in their upper limb functions and activities of daily living.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Adel, B.Sc.; Phone Number: 01554552868; Email: 10722020440502@pg.cu.edu.eg
• Study Contact Backup: Name: Haytham Ibrahim, M.Sc.; Phone Number: 01013657738; Email: 10722019485962@pg.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Ministry of Health
    • Contact: Haytham Ahmed, M.Sc.; Phone Number: 0453146570

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

Children will be included if they have the following:

1. Children diagnosed as hemiparetic cerebral palsy.
2. Children of both sexes in the age group ranging from 3 to 6 years.
3. Spasticity will be grade 1 and 1+ according to modified Ashworth scale.
4. They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS).
5. Children could understand and follow commands given by the therapist.

Exclusion criteria:

Children will be excluded if they have any of the following:

1. History of convulsions and epilepsy.
2. Children with impaired cognitive function.
3. Any surgical procedure for correction of deformity or soft tissue release in the past one year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: designed physiotherapy program; These exercises included: Passive stretching exercises for elbow and wrist flexors. Weight-bearing exercises for the upper limbs. Stimulation of the protective reactions of the upper limbs in all directions. Strengthening exercises for antagonists of the spastic muscles, including elbow and wrist extensors, using different toys and motivation to encourage the children to perform the desired exercises (El-shamy, 2018). The treatment session for 1hour 5 days / week for 4 weeks.	Procedure: Physical therapy exercises.; Exercises to treat hemiparetic cerebral palsy
Experimental: Whole body vibration.; Each child will be seated on an armless chair in front of the platform and instructed to flex both shoulders at 90°, slightly bend both elbows, and then bend the trunk forward to allow both hands to be placed on the platform. Each subject will be allowed to hold the palms slightly off the platform to minimize discomfort and prevent strong stimulation of the organs, eyes, and head.	Procedure: Physical therapy exercises.; Exercises to treat hemiparetic cerebral palsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder joint abduction range of motion.	Measurement of range of motion of shoulder joint abduction using the digital Goniometer.	Change from Baseline shoulder joint abduction range of motion at one month.
Change in shoulder joint flexion range of motion.	Measurement of range of motion of shoulder joint flexion using the digital Goniometer.	Change from Baseline shoulder joint flexion range of motion at one month.
Change in elbow joint flexion range of motion.	Measurement of range of motion of elbow joint flexion using the digital Goniometer.	Change from Baseline elbow joint flexion range of motion at one month.
Change in elbow joint extension range of motion.	Measurement of range of motion of elbow joint extension using the digital Goniometer.	Change from Baseline elbow joint extension range of motion at one month.
Change in wrist joint extension range of motion.	Measurement of range of motion of wrist joint extension using the digital Goniometer.	Change from Baseline wrist joint extension range of motion at one month.
Change in wrist joint flexion range of motion.	Measurement of range of motion of wrist joint flexion using the digital Goniometer.	Change from Baseline wrist joint flexion range of motion at one month.
Change in strength of shoulder abductors muscles.	Measurement of strength of shoulder abductors muscles using the Lafayette handheld dynamometer	Change from Baseline strength of shoulder abductors muscles at one month.
Change in strength of shoulder flexors muscles.	Measurement of strength of shoulder flexors muscles using the Lafayette handheld dynamometer	Change from Baseline strength of shoulder flexors muscles at one month.
Change in strength of elbow flexors muscles.	Measurement of strength of elbow flexors muscles using the Lafayette handheld dynamometer	Change from Baseline strength of elbow flexors muscles at one month.
Change in strength of elbow extensors muscles.	Measurement of strength of elbow extensors muscles using the Lafayette handheld dynamometer	Change from Baseline strength of elbow extensors muscles at one month.
Change in strength of wrist extensors muscles.	Measurement of strength of wrist extensors muscles using the Lafayette handheld dynamometer	Change from Baseline strength of wrist extensors muscles at one month.
Change in strength of wrist flexors muscles.	Measurement of strength of wrist flexors muscles using the Lafayette handheld dynamometer	Change from Baseline strength of wrist flexors muscles at one month.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Haytham Morsi, M.Sc., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 27, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: P.T.1993

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