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

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ClinicalTrials.gov Identifier: NCT02189551
Recruitment Status : Terminated (an additional intervention, amendet to the study (3rd arm, not described here), has not received clearance by regulatory authorities)
First Posted : July 14, 2014
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Swiss Commission for Technology and Innovation
Swiss Federal Institute of Technology
Hocoma AG
University of Zurich
Information provided by (Responsible Party):
Cereneo AG

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Post Stroke Gait Training Behavioral: Gait training with Lokomat Pro Behavioral: Gait training with Lokomat Pro FreeD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189551


Locations
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Switzerland
Cereneo, Center For Rehabilitation and Neurology
Vitznau, LU, Switzerland, 6354
Sponsors and Collaborators
Cereneo AG
Swiss Commission for Technology and Innovation
Swiss Federal Institute of Technology
Hocoma AG
University of Zurich
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Cereneo AG
ClinicalTrials.gov Identifier: NCT02189551    
Other Study ID Numbers: EKNZ: 2014-052
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018