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Whole Body Vibration for Hemiparetic Cerebral Palsy

Primary Purpose

Physical Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physical therapy exercises.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Therapy

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria: Children will be included if they have the following: Children diagnosed as hemiparetic cerebral palsy. Children of both sexes in the age group ranging from 3 to 6 years. Spasticity will be grade 1 and 1+ according to modified Ashworth scale. They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS). Children could understand and follow commands given by the therapist. Exclusion criteria: Children will be excluded if they have any of the following: History of convulsions and epilepsy. Children with impaired cognitive function. Any surgical procedure for correction of deformity or soft tissue release in the past one year.

Sites / Locations

  • Ministry of HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

designed physiotherapy program

Whole body vibration.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in shoulder joint abduction range of motion.
Measurement of range of motion of shoulder joint abduction using the digital Goniometer.
Change in shoulder joint flexion range of motion.
Measurement of range of motion of shoulder joint flexion using the digital Goniometer.
Change in elbow joint flexion range of motion.
Measurement of range of motion of elbow joint flexion using the digital Goniometer.
Change in elbow joint extension range of motion.
Measurement of range of motion of elbow joint extension using the digital Goniometer.
Change in wrist joint extension range of motion.
Measurement of range of motion of wrist joint extension using the digital Goniometer.
Change in wrist joint flexion range of motion.
Measurement of range of motion of wrist joint flexion using the digital Goniometer.
Change in strength of shoulder abductors muscles.
Measurement of strength of shoulder abductors muscles using the Lafayette handheld dynamometer
Change in strength of shoulder flexors muscles.
Measurement of strength of shoulder flexors muscles using the Lafayette handheld dynamometer
Change in strength of elbow flexors muscles.
Measurement of strength of elbow flexors muscles using the Lafayette handheld dynamometer
Change in strength of elbow extensors muscles.
Measurement of strength of elbow extensors muscles using the Lafayette handheld dynamometer
Change in strength of wrist extensors muscles.
Measurement of strength of wrist extensors muscles using the Lafayette handheld dynamometer
Change in strength of wrist flexors muscles.
Measurement of strength of wrist flexors muscles using the Lafayette handheld dynamometer

Secondary Outcome Measures

Full Information

First Posted
May 27, 2023
Last Updated
June 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05896111
Brief Title
Whole Body Vibration for Hemiparetic Cerebral Palsy
Official Title
Effect of Whole Body Vibration on Upper Limb Range of Motion and Strength in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot testing to get sample.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
designed physiotherapy program
Arm Type
Experimental
Arm Description
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.
Arm Title
Whole body vibration.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy exercises.
Intervention Description
Exercises to treat hemiparetic cerebral palsy
Primary Outcome Measure Information:
Title
Change in shoulder joint abduction range of motion.
Description
Measurement of range of motion of shoulder joint abduction using the digital Goniometer.
Time Frame
Change from Baseline shoulder joint abduction range of motion at one month.
Title
Change in shoulder joint flexion range of motion.
Description
Measurement of range of motion of shoulder joint flexion using the digital Goniometer.
Time Frame
Change from Baseline shoulder joint flexion range of motion at one month.
Title
Change in elbow joint flexion range of motion.
Description
Measurement of range of motion of elbow joint flexion using the digital Goniometer.
Time Frame
Change from Baseline elbow joint flexion range of motion at one month.
Title
Change in elbow joint extension range of motion.
Description
Measurement of range of motion of elbow joint extension using the digital Goniometer.
Time Frame
Change from Baseline elbow joint extension range of motion at one month.
Title
Change in wrist joint extension range of motion.
Description
Measurement of range of motion of wrist joint extension using the digital Goniometer.
Time Frame
Change from Baseline wrist joint extension range of motion at one month.
Title
Change in wrist joint flexion range of motion.
Description
Measurement of range of motion of wrist joint flexion using the digital Goniometer.
Time Frame
Change from Baseline wrist joint flexion range of motion at one month.
Title
Change in strength of shoulder abductors muscles.
Description
Measurement of strength of shoulder abductors muscles using the Lafayette handheld dynamometer
Time Frame
Change from Baseline strength of shoulder abductors muscles at one month.
Title
Change in strength of shoulder flexors muscles.
Description
Measurement of strength of shoulder flexors muscles using the Lafayette handheld dynamometer
Time Frame
Change from Baseline strength of shoulder flexors muscles at one month.
Title
Change in strength of elbow flexors muscles.
Description
Measurement of strength of elbow flexors muscles using the Lafayette handheld dynamometer
Time Frame
Change from Baseline strength of elbow flexors muscles at one month.
Title
Change in strength of elbow extensors muscles.
Description
Measurement of strength of elbow extensors muscles using the Lafayette handheld dynamometer
Time Frame
Change from Baseline strength of elbow extensors muscles at one month.
Title
Change in strength of wrist extensors muscles.
Description
Measurement of strength of wrist extensors muscles using the Lafayette handheld dynamometer
Time Frame
Change from Baseline strength of wrist extensors muscles at one month.
Title
Change in strength of wrist flexors muscles.
Description
Measurement of strength of wrist flexors muscles using the Lafayette handheld dynamometer
Time Frame
Change from Baseline strength of wrist flexors muscles at one month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Children will be included if they have the following: Children diagnosed as hemiparetic cerebral palsy. Children of both sexes in the age group ranging from 3 to 6 years. Spasticity will be grade 1 and 1+ according to modified Ashworth scale. They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS). Children could understand and follow commands given by the therapist. Exclusion criteria: Children will be excluded if they have any of the following: History of convulsions and epilepsy. Children with impaired cognitive function. Any surgical procedure for correction of deformity or soft tissue release in the past one year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Adel, B.Sc.
Phone
01554552868
Email
10722020440502@pg.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Haytham Ibrahim, M.Sc.
Phone
01013657738
Email
10722019485962@pg.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haytham Morsi, M.Sc.
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Ministry of Health
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haytham Ahmed, M.Sc.
Phone
0453146570

12. IPD Sharing Statement

Plan to Share IPD
No

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Whole Body Vibration for Hemiparetic Cerebral Palsy

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