Back to resultsEffect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
Primary Purpose
Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical therapy program
whole body vibration (without extra weight vest)
whole body vibration (with weight vest)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, balance, muscle strength, spastic diplegia, HUMAC balance system
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group I
Experimental group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
balance
Human computer balance system will be used to assess balance to assess center op pressure and limits of stability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05606926
Brief Title
Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
Official Title
Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, balance, muscle strength, spastic diplegia, HUMAC balance system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Other
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physical therapy program
Intervention Description
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
Intervention Name(s)
whole body vibration (without extra weight vest)
Intervention Description
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
Intervention Name(s)
whole body vibration (with weight vest)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trunk control
Description
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
Time Frame
three months
Title
Gross motor function
Description
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
Time Frame
three months
Title
balance
Description
Human computer balance system will be used to assess balance to assess center op pressure and limits of stability
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira M Abd-elmonem, PhD
Phone
01155553316
Email
Dramira.salim2020@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HOSAM A ALMOHANDES, B.S.C
Organizational Affiliation
Cairo university, faculty of physical therapy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nahla M Ibrahim, Phd
Organizational Affiliation
Cairo university, faculty of physical therapy
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
We'll reach out to this number within 24 hrs