Validation of a Novel Robot-aided Assessment of Gait Ability
Validation of Lokomat-aided Assessment of Gait Ability
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 19, 2017
December 1, 2017
1.5 years
April 20, 2015
December 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraclass Correlation Coefficient between Lokomat score.
Reliability of Lokomat assessment
up to one week
Study Arms (1)
Lokomat assessment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- individuals \>1 year post Spinal Cord Injury or able bodied persons
You may not qualify if:
- presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik Balgrist
Zurich, Switzerland
Related Publications (1)
Maggioni S, Lunenburger L, Riener R, Curt A, Bolliger M, Melendez-Calderon A. Assessing walking ability using a robotic gait trainer: opportunities and limitations of assist-as-needed control in spinal cord injury. J Neuroeng Rehabil. 2023 Sep 21;20(1):121. doi: 10.1186/s12984-023-01226-4.
PMID: 37735690DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2015
First Posted
April 23, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 19, 2017
Record last verified: 2017-12