Back to resultsEffect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
Primary Purpose
Spastic Diplegia Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spring gravity bar
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Diplegia Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Their age will be extended from 7 to 10 years.
- They can walk with limitation or holding on according to GMFCS (level II & II).
- 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.
Sites / Locations
- Cairo University Pediatric HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
They will receive the same traditional physical therapy exercise program in addition to gait training on spring gravity bar for one hour
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04628247
Brief Title
Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
Official Title
Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegia Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
They will receive the same traditional physical therapy exercise program in addition to gait training on spring gravity bar for one hour
Intervention Type
Device
Intervention Name(s)
Spring gravity bar
Intervention Description
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
Primary Outcome Measure Information:
Title
Two dimensional gait analysis
Description
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
Time Frame
20 minute
Title
Dynamic gait index
Description
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
Time Frame
20 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Their age will be extended from 7 to 10 years.
They can walk with limitation or holding on according to GMFCS (level II & II).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baseem Zaki Mahmoud, BSc physiotherapy
Phone
002001553896691
Email
baseem2022@googlemail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nahla Mohamed Ibrahium, Lecture
Phone
002001001937744
Email
Nahlahegazy1983@googlemail.com
Facility Information:
Facility Name
Cairo University Pediatric Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
We'll reach out to this number within 24 hrs