Back to resultsValidation of a Novel Robot-aided Assessment of Gait Ability
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lokomat gait trainer
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, adaptive control, assessment, assist-as-needed, walking ability, Lokomat
Eligibility Criteria
Inclusion Criteria:
- individuals >1 year post Spinal Cord Injury or able bodied persons
Exclusion Criteria:
- presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures
Sites / Locations
- Universitätsklinik Balgrist
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lokomat assessment
Arm Description
Outcomes
Primary Outcome Measures
Intraclass Correlation Coefficient between Lokomat score.
Reliability of Lokomat assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02425332
Brief Title
Validation of a Novel Robot-aided Assessment of Gait Ability
Official Title
Validation of Lokomat-aided Assessment of Gait Ability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, adaptive control, assessment, assist-as-needed, walking ability, Lokomat
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lokomat assessment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lokomat gait trainer
Primary Outcome Measure Information:
Title
Intraclass Correlation Coefficient between Lokomat score.
Description
Reliability of Lokomat assessment
Time Frame
up to one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
individuals >1 year post Spinal Cord Injury or able bodied persons
Exclusion Criteria:
presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures
Facility Information:
Facility Name
Universitätsklinik Balgrist
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Validation of a Novel Robot-aided Assessment of Gait Ability
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