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

August 14, 2018 updated by: Cereneo AG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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

  • Switzerland
    • LU
      • Vitznau, LU, Switzerland, 6354
        • Cereneo, Center For Rehabilitation and Neurology

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lokomat Pro
gait robot established on the market
Behavioral: Gait training with Lokomat Pro
Experimental: Lokomat Pro FreeD
gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market
Behavioral: Gait training with Lokomat Pro FreeD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral hip movement
Time Frame: 30 min training during day 1 (next session after inclusion)
during 30 min training with each device, lateral hip movements will be assessed
30 min training during day 1 (next session after inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: day 2 and 3
Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
day 2 and 3
Patient motivation
Time Frame: day 2 and 3
Patient motivation, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
day 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cereneo AG

Collaborators

University of Zurich
Swiss Federal Institute of Technology
Swiss Commission for Technology and Innovation
Hocoma AG

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

June 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • EKNZ: 2014-052

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.

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