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

NCT05330741 | Unknown DMC

• 1 other identifier: P.T.REC/012/003598
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Down Syndrome

Keywords

Whole-Body Vibration; Gravity Force Stimulation; Biodex Balance System; Down Syndrome

Outcome Measures

Primary Outcomes (1)

• Postural Stability

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

  Up to 12 weeks

Secondary Outcomes (1)

• Functional Mobility

  Up to 12 weeks

Study Arms (3)

Designed Physical Therapy Program

EXPERIMENTAL

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.

Other: Designed Physical Therapy Program

Whole-Body Vibration

EXPERIMENTAL

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.

Other: Designed Physical Therapy Program; Other: Whole-Body Vibration

Gravity Force Stimulation

EXPERIMENTAL

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.

Other: Designed Physical Therapy Program; Other: Gravity Force Stimulation

Interventions

Designed Physical Therapy Program OTHER

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.

Designed Physical Therapy Program; Gravity Force Stimulation; Whole-Body Vibration

Whole-Body Vibration OTHER

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.

Whole-Body Vibration

Gravity Force Stimulation OTHER

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)

Gravity Force Stimulation

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Central Study Contacts

Eman Wagdy

CONTACT

01008079576; Eman.wagdy@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: By random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Designed Physical Therapy program, Whole Body Vibration and, Gravity Force Stimulation

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: April 9, 2022
• Primary Completion: July 9, 2022
• Study Completion: July 9, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04