Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children

Sponsor

Ragaee Saeed Mahmoud (Other)

Overall Status

Recruiting

CT.gov ID

NCT06036069

Collaborator

(none)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

17.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Other: Conventional physical therapy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control studyRandomized control study

Masking:

Single (Outcomes Assessor)

Masking Description:

Single (outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional physical therapy group It consisted of 20 children received conventional physical therapy	Other: Conventional physical therapy 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. Other Names: Physical therapy program
Experimental: Core stability exercises group It consisted of 20 children received conventional physical therapy and core stability exercises	Other: Conventional physical therapy 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. Other Names: Physical therapy program
Experimental: Whole body vibration It consisted of 20 children received conventional physical therapy and whole body vibration exercises	Other: Conventional physical therapy 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. Other Names: Physical therapy program

Arm

Intervention/Treatment

Experimental: Conventional physical therapy group

It consisted of 20 children received conventional physical therapy

Other: Conventional physical therapy

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.

Other Names:

Physical therapy program

Experimental: Core stability exercises group

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

Other: Conventional physical therapy

Other Names:

Physical therapy program

Experimental: Whole body vibration

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

Other: Conventional physical therapy

Other Names:

Physical therapy program

Outcome Measures

Primary Outcome Measures

Biodex Balance System [before intervention and after 12 weeks of intervention]
it is a reliable and objective assessment in order to quantify dynamic balance

Secondary Outcome Measures

Hand-held dynamometer [before intervention and after 12 weeks of intervention]
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ragaee Saeed Mahmoud	Giza	Faisal	Egypt

Sponsors and Collaborators

Ragaee Saeed Mahmoud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ragaee Saeed Mahmoud, Lecturer, South Valley University

ClinicalTrials.gov Identifier:

NCT06036069

Other Study ID Numbers:

P.T.REC/012/004335

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ragaee Saeed Mahmoud, Lecturer, South Valley University

Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration

Additional relevant MeSH terms:

Down Syndrome

Syndrome

Study Results

No Results Posted as of Sep 13, 2023