search
Back to results

Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional physical therapy
Sponsored by
Ragaee Saeed Mahmoud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged between 10 to 16 years. Able to recognize commands given to them. Understand our verbal command and encouragement. Stand and walk independently without repeated falling. Exclusion Criteria: Children with any neurological (signs of epilepsy and instability of atlantoaxial joint). Musculoskeletal, or mobility disorders. Cardiac anomalies. Vision or hearing loss.

Sites / Locations

  • Ragaee Saeed MahmoudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conventional physical therapy group

Core stability exercises group

Whole body vibration

Arm Description

It consisted of 20 children received conventional physical therapy

It consisted of 20 children received conventional physical therapy and core stability exercises

It consisted of 20 children received conventional physical therapy and whole body vibration exercises

Outcomes

Primary Outcome Measures

Biodex Balance System
it is a reliable and objective assessment in order to quantify dynamic balance

Secondary Outcome Measures

Hand-held dynamometer
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method

Full Information

First Posted
September 2, 2023
Last Updated
October 11, 2023
Sponsor
Ragaee Saeed Mahmoud
search

1. Study Identification

Unique Protocol Identification Number
NCT06036069
Brief Title
Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome
Official Title
Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ragaee Saeed Mahmoud

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
Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children
Detailed Description
Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control study
Masking
Outcomes Assessor
Masking Description
Single (outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy group
Arm Type
Experimental
Arm Description
It consisted of 20 children received conventional physical therapy
Arm Title
Core stability exercises group
Arm Type
Experimental
Arm Description
It consisted of 20 children received conventional physical therapy and core stability exercises
Arm Title
Whole body vibration
Arm Type
Experimental
Arm Description
It consisted of 20 children received conventional physical therapy and whole body vibration exercises
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Other Intervention Name(s)
Physical therapy program
Intervention Description
Standing with feet together while the therapist was sitting behind and manually locking the child knees. Step standing with the therapist behind the child. High step standing and trying to keep balanced. The child stood on exercise mattress. Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress. Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction. Standing with manual locking of the knees. Changing position. Gait training. Static and dynamic muscle contraction.
Primary Outcome Measure Information:
Title
Biodex Balance System
Description
it is a reliable and objective assessment in order to quantify dynamic balance
Time Frame
before intervention and after 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Hand-held dynamometer
Description
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
Time Frame
before intervention and after 12 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged between 10 to 16 years. Able to recognize commands given to them. Understand our verbal command and encouragement. Stand and walk independently without repeated falling. Exclusion Criteria: Children with any neurological (signs of epilepsy and instability of atlantoaxial joint). Musculoskeletal, or mobility disorders. Cardiac anomalies. Vision or hearing loss.
Facility Information:
Facility Name
Ragaee Saeed Mahmoud
City
Giza
State/Province
Faisal
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragaee Mahmoud
Phone
00201223611112
Email
ragaeesaeedpt10@gmail.com
First Name & Middle Initial & Last Name & Degree
Reham Mahmoud
Phone
00201015447798
Email
rsm_211pt@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome

We'll reach out to this number within 24 hrs