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Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy

Primary Purpose

Cerebral Palsy, Hemiparesis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
whole body vibration
Functional strength training
Sponsored by
Amany Ibrahim AbdElhamed Sabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, Hemiparesis, balance, whole body vibration, functional strength training

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The children in the study will be selected according to the following criteria: Their chronological age ranged from five to eight years old. Spasticity Grade I and II according to Modified Ashworth Scale. They will be on Level II and III according to Gross Motor Functional Classification System (GMFCS) Have the ability to walk independently. They can understand order and follow instruction. The child will be able to follow verbal commands and instructions. They can firmly grasp the rails of biodex device. Exclusion Criteria: Children with visual or auditory problems. Children with uncontrolled convulsions. Children with fixed contractures and deformities. Children with surgical intervention less than one year. Children injected by BOTOX in the calf muscle from less than one year. Children had heart disease. Children with epilepsy. Children with severe diabetes. Children with severe vascular disease

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

whole body vibration

Functional strength training

Arm Description

will receive whole body Vibration training that elicits a warm up effect to improves muscle power and balance in addition to designed physical program.

will receive Functional strength training that focuses on the movement pattern quality and treats functional movement and provides postural stability while promoting balance independence with confidence

Outcomes

Primary Outcome Measures

balance improvement
we will use pediatric balance scale and Biodex balance system to measure balance

Secondary Outcome Measures

gross motor performance
we will use Gross Motor Function Measure 88 (GMFM-88) to measure gross motor performance

Full Information

First Posted
June 24, 2023
Last Updated
July 6, 2023
Sponsor
Amany Ibrahim AbdElhamed Sabra
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1. Study Identification

Unique Protocol Identification Number
NCT05936554
Brief Title
Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy
Official Title
Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy: Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2023 (Anticipated)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
September 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amany Ibrahim AbdElhamed Sabra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis
Detailed Description
Hemiparesis is a type of hemiplegia where mild muscle weakness causes balance disturbances because one side of the body is affected such as the arm, chest leg or face. Muscle weakness is commonly associated with abnormal bone development, leading to increased susceptibility to fractures, most cerebral palsy children have deficits in balance, coordination, and gait throughout childhood and adulthood. So, it is essential to seek an ideal physical therapy program to help in solving such widespread problem. Balance control is important for competence in the performance of most functional skills, helping children to recover from unexpected balance disturbances, either due to slips and trips or to self- induced instability when making a movement that brings them toward the edge of their limit of stability Whole body vibration is mechanical oscillation, defined by amplitude and frequency, generates a force that acts on whole body. It is a training method for muscle tone modulation that is increasingly used in a variety of clinical situations. Functional strength training (FST) is an effective method of exercise therapy. It can be combined with traditional physical therapy methods and can be successfully combined with most rehabilitation and exercise equipment. It provides postural stability while promoting independence with confidence. The current study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiparesis
Keywords
cerebral palsy, Hemiparesis, balance, whole body vibration, functional strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
whole body vibration
Arm Type
Active Comparator
Arm Description
will receive whole body Vibration training that elicits a warm up effect to improves muscle power and balance in addition to designed physical program.
Arm Title
Functional strength training
Arm Type
Active Comparator
Arm Description
will receive Functional strength training that focuses on the movement pattern quality and treats functional movement and provides postural stability while promoting balance independence with confidence
Intervention Type
Device
Intervention Name(s)
whole body vibration
Intervention Description
to improve muscle power and balance.
Intervention Type
Other
Intervention Name(s)
Functional strength training
Intervention Description
used in treatment of hemiparetic cerebral palsy and provides postural stability while promoting balance independence with confidence and muscle power
Primary Outcome Measure Information:
Title
balance improvement
Description
we will use pediatric balance scale and Biodex balance system to measure balance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
gross motor performance
Description
we will use Gross Motor Function Measure 88 (GMFM-88) to measure gross motor performance
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The children in the study will be selected according to the following criteria: Their chronological age ranged from five to eight years old. Spasticity Grade I and II according to Modified Ashworth Scale. They will be on Level II and III according to Gross Motor Functional Classification System (GMFCS) Have the ability to walk independently. They can understand order and follow instruction. The child will be able to follow verbal commands and instructions. They can firmly grasp the rails of biodex device. Exclusion Criteria: Children with visual or auditory problems. Children with uncontrolled convulsions. Children with fixed contractures and deformities. Children with surgical intervention less than one year. Children injected by BOTOX in the calf muscle from less than one year. Children had heart disease. Children with epilepsy. Children with severe diabetes. Children with severe vascular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy
Phone
01090243185
Email
amanyibrahimsabra@gmail.com
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Kafr Ash Shaykh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of physical therapy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
For assessment : Modified Ashworth scale, Gross Motor Function Classification System Expanded and Revised (GMFCS-ER), The six-minute walk test (6MWT), Biodex stability system and pediatric balance scale. For Treatment: At first both groups will receive 60 minutes of designed physical therapy program, which consisted of stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles: kneeling exercises, and standing and gait training as warming up then group I will receive whole body vibration (WBV) for 25 minutes and group II will receive functional strength training program (FST) for 30 minutes

Learn more about this trial

Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy

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