Validation of a Novel Robot-aided Assessment of Gait Ability

Spinal Cord Injury Clinical Trial

Official title:

Validation of Lokomat-aided Assessment of Gait Ability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425332
• Other study ID #: KEK-ZH-2015 0020/PB_2016-00466
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: December 18, 2017
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Lokomat gait trainer

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraclass Correlation Coefficient between Lokomat score.	Reliability of Lokomat assessment	up to one week