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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05330741
• Other study ID #: P.T.REC/012/003598
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 9, 2022
• Est. completion date: July 9, 2022

Study information

• Verified date: April 2022
• Source: Beni-Suef University
• Contact: Eman Wagdy
• Phone: 01008079576
• Email: Eman.wagdy[@]pt.bsu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 9, 2022
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Other:
• Designed Physical Therapy Program
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.
• Whole-Body Vibration
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.
• Gravity Force Stimulation
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to 12 weeks