Whole Body Vibration for Hemiparetic Cerebral Palsy

Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896111
• Other study ID #: P.T.1993
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: Mahmoud Adel, B.Sc.
• Phone: 01554552868
• Email: 10722020440502[@]pg.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Physical Therapy

Intervention

Procedure:
• Physical therapy exercises.
Exercises to treat hemiparetic cerebral palsy

Locations

Country	Name	City	State
Egypt	Ministry of Health	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.