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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: physical therapy program; Other: whole body vibration (without extra weight vest); Other: whole body vibration (with weight vest)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.; 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.
Experimental: 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.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk control	The Trunk Control Measurement Scale is used to assess trunk control and consists of static and dynamic sitting balance in children aged 8 to 15 years with spastic CP	three months
Gross motor function	The Gross motor function measure-88 will be used to assess motor function in 88 items across five dimensions: (a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. dimensions D and E will be assessed in the current study The assessment of each item will be conducted carefully and scored according to the scale scoring key (scale from 0-3) with total score 100 and higher score represent better performance	three months
balance	Human computer balance system will be used to assess balance to assess center op pressure and limits of stability	three months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: HOSAM A ALMOHANDES, B.S.C, Cairo university, faculty of physical therapy; Study Chair: Nahla M Ibrahim, Phd, Cairo university, faculty of physical therapy

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: muscle strength; Cerebral palsy; balance; HUMAC balance system; spastic diplegia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: whole body vibration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No