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

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

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

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome
• Intervention / Treatment: Other: Conventional physical therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Faisal
    • Giza, Faisal, Egypt
      • Recruiting
      • Ragaee Saeed Mahmoud
      • Contact: Ragaee Mahmoud; Phone Number: 00201223611112; Email: ragaeesaeedpt10@gmail.com
      • Contact: Reham Mahmoud; Phone Number: 00201015447798; Email: rsm_211pt@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodex Balance System	it is a reliable and objective assessment in order to quantify dynamic balance	before intervention and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before intervention and after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Ragaee Saeed Mahmoud

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): January 20, 2024

Study Registration Dates

• First Submitted: September 2, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: P.T.REC/012/004335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No