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

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ClinicalTrials.gov Identifier: NCT06036069
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : October 13, 2023
Sponsor:
Information provided by (Responsible Party):
Ragaee Saeed Mahmoud, South Valley University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control study
Masking: Single (Outcomes Assessor)
Masking Description: Single (outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children
Estimated Study Start Date : October 15, 2023
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 20, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: Physical therapy program


Outcome Measures
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Primary Outcome Measures :
  1. Biodex Balance System [ Time Frame: before intervention and after 12 weeks of intervention ]
    it is a reliable and objective assessment in order to quantify dynamic balance


Secondary Outcome Measures :
  1. Hand-held dynamometer [ Time Frame: 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
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036069


Locations
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Egypt
Ragaee Saeed Mahmoud Recruiting
Giza, Faisal, Egypt
Contact: Ragaee Mahmoud    00201223611112    ragaeesaeedpt10@gmail.com   
Contact: Reham Mahmoud    00201015447798    rsm_211pt@yahoo.com   
Sponsors and Collaborators
Ragaee Saeed Mahmoud
More Information
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Responsible Party: Ragaee Saeed Mahmoud, Lecturer, South Valley University
ClinicalTrials.gov Identifier: NCT06036069    
Other Study ID Numbers: P.T.REC/012/004335
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: October 13, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ragaee Saeed Mahmoud, South Valley University:
Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn