Back to resultsThe Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
Primary Purpose
Brain Injury, Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
walking and balance performance evaluation
muscle strength, walking and balance performance
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury
Eligibility Criteria
Inclusion Criteria: 3 years of age and older Ambulate, with or without an aid - Exclusion Criteria: -
Sites / Locations
- Alyn Pediatric and Adolescent Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
a
Arm Description
TD
TBI
Cerebral palsy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00338858
First Posted
June 19, 2006
Last Updated
February 14, 2011
Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00338858
Brief Title
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
Official Title
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to explore the connection between gait variability parameters and balance performance in children with physical disability
Detailed Description
Step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (EEI) and rating of perceived exertion (OMNI scale).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
TD
Arm Title
2
Arm Type
Experimental
Arm Description
TBI
Arm Title
a
Arm Type
Experimental
Arm Description
Cerebral palsy
Intervention Type
Other
Intervention Name(s)
walking and balance performance evaluation
Intervention Type
Procedure
Intervention Name(s)
muscle strength, walking and balance performance
Intervention Description
HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
3 years of age and older Ambulate, with or without an aid
-
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hemda Rotem, PT
Organizational Affiliation
Alyn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyn Pediatric and Adolescent Rehabilitation Center
City
Jerusalem
ZIP/Postal Code
91090
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
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