Whole Body Vibration for Hemiparetic Cerebral Palsy

NCT05896111 | Unknown DMC

• 1 other identifier: P.T.1993
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Therapy

Outcome Measures

Primary Outcomes (12)

• 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.

Study Arms (2)

designed physiotherapy program

EXPERIMENTAL

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.

Whole body vibration.

EXPERIMENTAL

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.

Interventions

Physical therapy exercises. PROCEDURE

Exercises to treat hemiparetic cerebral palsy

Whole body vibration.; designed physiotherapy program

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ministry of Health

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Haytham Morsi, M.Sc.

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Adel, B.Sc.

CONTACT

01554552868; 10722020440502@pg.cu.edu.eg

Haytham Ibrahim, M.Sc.

CONTACT

01013657738; 10722019485962@pg.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior.

Model Details: pilot testing to get sample.

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 9, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)