Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia

NCT ID: NCT05606926

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-11-30

Brief Summary

Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. However, adding extra weight during Whole body vibration for children with cerebral palsy as a means of enhancing the potential effects of Whole body vibration is unknown. Therefore, the aim of this study is to examine the effect of Whole body vibration with weighted vest on trunk control, balance and gross motor function in children with spastic diplegia.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I

15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months.

Group Type: OTHER

physical therapy program

Intervention Type: OTHER

Flexibility exercises to restore joint mobility of soft tissues, Static and dynamic balance exercises, Functional gait training , Functional strengthening exercises will be conducted three times a week, for three consecutive months.

whole body vibration (without extra weight vest)

Intervention Type: OTHER

9 minutes of three sets of 3-min semi-squats on the vibration platform. three times a week, for three consecutive months.

Experimental group

15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest.

Group Type: EXPERIMENTAL

physical therapy program

Intervention Type: OTHER

Flexibility exercises to restore joint mobility of soft tissues, Static and dynamic balance exercises, Functional gait training , Functional strengthening exercises will be conducted three times a week, for three consecutive months.

whole body vibration (with weight vest)

Intervention Type: OTHER

The extra-weight applied in the vest will be calculated as 10% of the child body weight. The vest is designed to allow small bags of sand with different weights that are distributed equally on anterior-posterior and mediolateral plans.

Interventions

physical therapy program

Flexibility exercises to restore joint mobility of soft tissues, Static and dynamic balance exercises, Functional gait training , Functional strengthening exercises will be conducted three times a week, for three consecutive months.

Intervention Type: OTHER

whole body vibration (without extra weight vest)

9 minutes of three sets of 3-min semi-squats on the vibration platform. three times a week, for three consecutive months.

Intervention Type: OTHER

whole body vibration (with weight vest)

The extra-weight applied in the vest will be calculated as 10% of the child body weight. The vest is designed to allow small bags of sand with different weights that are distributed equally on anterior-posterior and mediolateral plans.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Their age will range from 8-12 years, from both sexes.
• Level II and III of gross motor functional classification system
• Grade 1 and 1+ spasticity according to the Modified Ashworth Scale
• Ability to understand and follow simple verbal instruc

Exclusion Criteria

• Uncontrolled epilepsy.
• Mental retardation or autistic features.
• Medication changes that could affect muscle strength or tone
• Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
• Structural or fixed soft tissue deformities of the lower and/or upper extremities.
• Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
• Botox injection in the lower and/or upper extremities in the past 6 months.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mahmoud Abd-elmonem

Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HOSAM A ALMOHANDES, B.S.C

Role: STUDY_DIRECTOR

Cairo university, faculty of physical therapy

Nahla M Ibrahim, Phd

Role: STUDY_CHAIR

Cairo university, faculty of physical therapy

Central Contacts

Amira M Abd-elmonem, PhD

Role: CONTACT

Dramira.salim2020@gmail.com

01155553316

Other Identifiers

whole body vibration

Identifier Type: -

Identifier Source: org_study_id