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

NCT05606926 | Unknown

• 1 other identifier: whole body vibration
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cerebral palsy; balance; muscle strength; spastic diplegia; HUMAC balance system

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group I

OTHER

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; Other: whole body vibration (without extra weight vest)

Experimental group

EXPERIMENTAL

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; Other: whole body vibration (with weight vest)

Interventions

physical therapy program 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.

Experimental group; Group I

whole body vibration (without extra weight vest) OTHER

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

Group I

whole body vibration (with weight vest) 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.

Experimental group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• HOSAM A ALMOHANDES, B.S.C

  Cairo university, faculty of physical therapy

  STUDY DIRECTOR

• Nahla M Ibrahim, Phd

  Cairo university, faculty of physical therapy

  STUDY CHAIR

Central Study Contacts

Amira M Abd-elmonem, PhD

CONTACT

01155553316; Dramira.salim2020@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: November 7, 2022
• Study Start: January 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: December 5, 2022

Record last verified: 2022-12