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Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome

Primary Purpose

Down Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Designed Physical Therapy Program
Whole-Body Vibration
Gravity Force Stimulation
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Whole-Body Vibration, Gravity Force Stimulation, Biodex Balance System, Down Syndrome

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children ages will be ranged from 8 to 10 years old.
  2. Functional hearing and vision.
  3. Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale)
  4. Independent standing and walking.

Exclusion Criteria:

  1. Synptomatic pain.
  2. Musculoskeletal problems or/ atlanto-axial instability.
  3. Rheumatic and congenital heart disease
  4. History of previous surgical operation
  5. Regular participation in any sport activities.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Designed Physical Therapy Program

    Whole-Body Vibration

    Gravity Force Stimulation

    Arm Description

    Designed Physical Therapy Program Down syndrome children will receive the designed physical therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks.

    Designed physical therapy program in addition to whole-body vibration. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to whole-body vibration with an amplitude of 2 mm, vibration frequency ranged from 25 to 30 Hz and, vibration time ranged from 5 to10 minutes. The duration of treatment will be 3 times/week for 12 weeks.

    Designed physical therapy program in addition to gravity force stimulation. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to gravity force stimulation with 10 repetitions for each position. The duration of treatment will be 3 times/week for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Postural Stability
    Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.

    Secondary Outcome Measures

    Functional Mobility
    Six-minute walk test will be used for measuring functional mobility. It is a sub-maximal test of aerobic capacity, in which the subjects walk as far as possible in 6 minutes (min.) around a premeasured distance

    Full Information

    First Posted
    April 8, 2022
    Last Updated
    April 8, 2022
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05330741
    Brief Title
    Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome
    Official Title
    Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 9, 2022 (Anticipated)
    Primary Completion Date
    July 9, 2022 (Anticipated)
    Study Completion Date
    July 9, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with Down syndrome.
    Detailed Description
    Down Syndrome (DS) is one of genetic disorders characterized by some common clinical and functional features. Most children with Down syndrome have deficits in postural stability or balance, co-ordination, gait, and functional mobility throughout childhood and adulthood. Postural control dysfunctions are the most common problems found in children with DS leads them to be more inactive, which contributes to functional mobility problems. Several techniques that involve proprioceptive, vestibular, and visual inputs are so beneficial to children with DS. Whole-body vibration (WBV) is one of the training methods that use high-frequency mechanical stimuli generated by a vibrating platform and transmitted through the body, leading to bone loading and sensory receptor stimulation. Gravity force stimulation (GFS) has a strong impact on the child's sensory system helping to normalize the system through exercises that send strong messages to the brain to regulate the tactile, proprioceptive and vestibular components. Hence, there is need to compare between the effects of whole-body vibration training and gravity force stimulation on postural stability in children with Down syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Down Syndrome
    Keywords
    Whole-Body Vibration, Gravity Force Stimulation, Biodex Balance System, Down Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Designed Physical Therapy program, Whole Body Vibration and, Gravity Force Stimulation
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    By random generator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Designed Physical Therapy Program
    Arm Type
    Experimental
    Arm Description
    Designed Physical Therapy Program Down syndrome children will receive the designed physical therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks.
    Arm Title
    Whole-Body Vibration
    Arm Type
    Experimental
    Arm Description
    Designed physical therapy program in addition to whole-body vibration. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to whole-body vibration with an amplitude of 2 mm, vibration frequency ranged from 25 to 30 Hz and, vibration time ranged from 5 to10 minutes. The duration of treatment will be 3 times/week for 12 weeks.
    Arm Title
    Gravity Force Stimulation
    Arm Type
    Experimental
    Arm Description
    Designed physical therapy program in addition to gravity force stimulation. Down syndrome children will receive the designed physical therapy program for 1 hour in addition to gravity force stimulation with 10 repetitions for each position. The duration of treatment will be 3 times/week for 12 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Designed Physical Therapy Program
    Intervention Description
    The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
    Intervention Type
    Other
    Intervention Name(s)
    Whole-Body Vibration
    Intervention Description
    The designed physical therapy program (mentioned before) + Whole-body vibration (WBV) training, child will be asked to stand with slightly flexed knees (30 degrees of knee flexion), and both feet will be placed at an equal distance from the center of the platform to achieve an equal distribution of body weight over both feet. The device will set to produce a peak-to-peak sinusoidal vibration with an amplitude of 2 mm and a vibration frequency ranged from 25 to 30 Hz. WBV will applied for (30 sec. of WBV, 1 min rest, 10 repetitions), (45 sec. of WBV, 1 min rest, 10 repetitions), (60 sec. of WBV, 1 min rest, 10 repetitions) in the 1st, 2nd. and 3rd. months respectively.
    Intervention Type
    Other
    Intervention Name(s)
    Gravity Force Stimulation
    Intervention Description
    The designed physical therapy program (mentioned before) + Gravity force stimulation child will be asked to maintain his balance on GFS during each of the following positions as a progression (standing and walking on the surface of two beams connecting the two boxes - standing and walking crossly on the surface of one beam connecting the two boxes - standing and walking sideward on the surface of one beam connecting the two boxes - standing and walking on the edge of the two beams - standing and walking on the edge of one beam: most difficult)
    Primary Outcome Measure Information:
    Title
    Postural Stability
    Description
    Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
    Time Frame
    Up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Functional Mobility
    Description
    Six-minute walk test will be used for measuring functional mobility. It is a sub-maximal test of aerobic capacity, in which the subjects walk as far as possible in 6 minutes (min.) around a premeasured distance
    Time Frame
    Up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children ages will be ranged from 8 to 10 years old. Functional hearing and vision. Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale) Independent standing and walking. Exclusion Criteria: Synptomatic pain. Musculoskeletal problems or/ atlanto-axial instability. Rheumatic and congenital heart disease History of previous surgical operation Regular participation in any sport activities.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Wagdy
    Phone
    01008079576
    Email
    Eman.wagdy@pt.bsu.edu.eg

    12. IPD Sharing Statement

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    Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome

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