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Validation of a Novel Robot-aided Assessment of Gait Ability

NCT ID: NCT02425332

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Keywords

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Spinal Cord Injury adaptive control assessment assist-as-needed walking ability Lokomat

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lokomat assessment

Group Type EXPERIMENTAL

Lokomat gait trainer

Intervention Type DEVICE

Interventions

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Lokomat gait trainer

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinik Balgrist

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 37735690 (View on PubMed)

Other Identifiers

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KEK-ZH-2015 0020/PB_2016-00466

Identifier Type: -

Identifier Source: org_study_id