Whole Body Vibration for Hemiparetic Cerebral Palsy

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05896111
Collaborator
(none)
40
1
2
23
1.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Physical therapy exercises.
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
pilot testing to get sample.pilot testing to get sample.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Whole Body Vibration on Upper Limb Range of Motion and Strength in Children With Hemiparetic Cerebral Palsy
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in shoulder joint abduction range of motion. [Change from Baseline shoulder joint abduction range of motion at one month.]

    Measurement of range of motion of shoulder joint abduction using the digital Goniometer.

  2. Change in shoulder joint flexion range of motion. [Change from Baseline shoulder joint flexion range of motion at one month.]

    Measurement of range of motion of shoulder joint flexion using the digital Goniometer.

  3. Change in elbow joint flexion range of motion. [Change from Baseline elbow joint flexion range of motion at one month.]

    Measurement of range of motion of elbow joint flexion using the digital Goniometer.

  4. Change in elbow joint extension range of motion. [Change from Baseline elbow joint extension range of motion at one month.]

    Measurement of range of motion of elbow joint extension using the digital Goniometer.

  5. Change in wrist joint extension range of motion. [Change from Baseline wrist joint extension range of motion at one month.]

    Measurement of range of motion of wrist joint extension using the digital Goniometer.

  6. Change in wrist joint flexion range of motion. [Change from Baseline wrist joint flexion range of motion at one month.]

    Measurement of range of motion of wrist joint flexion using the digital Goniometer.

  7. Change in strength of shoulder abductors muscles. [Change from Baseline strength of shoulder abductors muscles at one month.]

    Measurement of strength of shoulder abductors muscles using the Lafayette handheld dynamometer

  8. Change in strength of shoulder flexors muscles. [Change from Baseline strength of shoulder flexors muscles at one month.]

    Measurement of strength of shoulder flexors muscles using the Lafayette handheld dynamometer

  9. Change in strength of elbow flexors muscles. [Change from Baseline strength of elbow flexors muscles at one month.]

    Measurement of strength of elbow flexors muscles using the Lafayette handheld dynamometer

  10. Change in strength of elbow extensors muscles. [Change from Baseline strength of elbow extensors muscles at one month.]

    Measurement of strength of elbow extensors muscles using the Lafayette handheld dynamometer

  11. Change in strength of wrist extensors muscles. [Change from Baseline strength of wrist extensors muscles at one month.]

    Measurement of strength of wrist extensors muscles using the Lafayette handheld dynamometer

  12. Change in strength of wrist flexors muscles. [Change from Baseline strength of wrist flexors muscles at one month.]

    Measurement of strength of wrist flexors muscles using the Lafayette handheld dynamometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ministry of Health Giza Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haytham Ibrahim Morsi, Senior., Cairo University
ClinicalTrials.gov Identifier:
NCT05896111
Other Study ID Numbers:
  • P.T.1993
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023