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Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia

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ClinicalTrials.gov Identifier: NCT04628247
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Baseem Zaki Mahmoud, Cairo University

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

Condition or disease Intervention/treatment Phase
Spastic Diplegia Cerebral Palsy Device: Spring gravity bar Not Applicable

Detailed 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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
They will receive the same traditional physical therapy exercise program in addition to gait training on spring gravity bar for one hour
 Device: Spring gravity bar
  1. contain two wooden board length (160 cm) and width (15 cm)
  2. contain pair of spring at every end of board
  3. two wooden board connect in the middle


Outcome Measures
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Primary Outcome Measures :
  1. Two dimensional gait analysis [ Time Frame: 20 minute ]
    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

  2. Dynamic gait index [ Time Frame: 20 minute ]
    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


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04628247


Contacts
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Contact: Baseem Zaki Mahmoud, BSc physiotherapy 002001553896691 baseem2022@googlemail.com
Contact: Nahla Mohamed Ibrahium, Lecture 002001001937744 Nahlahegazy1983@googlemail.com

Locations
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Egypt
Cairo University Pediatric Hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Cairo University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Baseem Zaki Mahmoud, BSc physiotherapy, Cairo University
ClinicalTrials.gov Identifier: NCT04628247    
Other Study ID Numbers: P.T.REC/012/002557
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations