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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04628247
Other study ID # P.T.REC/012/002557
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2020
Est. completion date December 2020

Study information

Verified date November 2020
Source Cairo University
Contact Baseem Zaki Mahmoud, BSc physiotherapy
Phone 002001553896691
Email baseem2022@googlemail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia


Description:

The purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria: 1. Their age will be extended from 7 to 10 years. 2. They can walk with limitation or holding on according to GMFCS (level II & II). 3. They can understand and follow instruction. Exclusion Criteria: - 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function. 3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.

Study Design


Intervention

Device:
Spring gravity bar
contain two wooden board length (160 cm) and width (15 cm) contain pair of spring at every end of board two wooden board connect in the middle

Locations

Country Name City State
Egypt Cairo University Pediatric Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Two dimensional gait analysis Two-dimensional (2D) video analysis may provide an accessible and affordable means of quantifying postural control deficits that can be implemented across a spectrum of care settings. Angular joint measures during weight lifting obtained using 2D motion analysis software have been shown to be highly correlated to goniometric measures . This system has also been shown to be reliable in quantifying range of motion during reaching and walking/running tasks 20 minute
Primary Dynamic gait index The Dynamic Gait Index is a sensitive and efficient tool for adults and therefore may be a useful tool for children. Dynamic Gait Index (DGI) is a performance-based tool that quantifiesthe dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking 20 minute
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