Validation of a Novel Robot-aided Assessment of Gait Ability
December 18, 2017 updated by: University of Zurich
Validation of Lokomat-aided Assessment of Gait Ability
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zürich, Switzerland
- Universitätsklinik Balgrist
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lokomat assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraclass Correlation Coefficient between Lokomat score.
Time Frame: up to one week
|
Reliability of Lokomat assessment
|
up to one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
April 20, 2015
First Submitted That Met QC Criteria
April 22, 2015
First Posted (Estimate)
April 23, 2015
Study Record Updates
Last Update Posted (Actual)
December 19, 2017
Last Update Submitted That Met QC Criteria
December 18, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-2015 0020/PB_2016-00466
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.