Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System

NCT ID: NCT02189551

Last Updated: 2018-08-15

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

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective).

Primary study endpoints will be a significantly higher rated patient comfort and or patient satisfaction using the new versions, compared with the established Lokomat. Furthermore, muscle activity and kinematic movement patterns will be expected to show more involved muscle groups and a walking pattern involving more degrees of freedom during use of the new version compared with the established Lokomat.

Exploratory endpoints will be a significantly stronger involvement of muscles needed for balance, more physiological walking patterns and more change on the lateral positioning of the feet due to training with the new version, compared with the established Lokomat.

Detailed Description

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Conditions

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Post Stroke Gait Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Lokomat Pro

gait robot established on the market

Group Type ACTIVE_COMPARATOR

Gait training with Lokomat Pro

Intervention Type BEHAVIORAL

Lokomat Pro FreeD

gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market

Group Type EXPERIMENTAL

Gait training with Lokomat Pro FreeD

Intervention Type BEHAVIORAL

Interventions

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Gait training with Lokomat Pro

Intervention Type BEHAVIORAL

Gait training with Lokomat Pro FreeD

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Lower extremity weakness due to stroke
* minor functional impairment (MRC \< 5)
* ability and willingness to participate

Exclusion Criteria

* severe spasticity of the lower extremities
* severe dementia
* severe depression
* any other contraindications against Lokomat training
* body weight \> 135 kg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Commission for Technology and Innovation

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

Hocoma AG

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Cereneo AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cereneo, Center For Rehabilitation and Neurology

Vitznau, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKNZ: 2014-052

Identifier Type: -

Identifier Source: org_study_id

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