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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05606926
• Other study ID #: whole body vibration
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: Amira M Abd-elmonem, PhD
• Phone: 01155553316
• Email: Dramira.salim2020[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	balance	Human computer balance system will be used to assess balance to assess center op pressure and limits of stability	three months