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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date August 15, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Post Stroke Gait Training
Intervention  ICMJE
  • Behavioral: Gait training with Lokomat Pro
  • Behavioral: Gait training with Lokomat Pro FreeD
Study Arms  ICMJE
  • Active Comparator: Lokomat Pro
    gait robot established on the market
    Intervention: 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
    Intervention: Behavioral: Gait training with Lokomat Pro FreeD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 14, 2018)
9
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189551
Other Study ID Numbers  ICMJE EKNZ: 2014-052
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cereneo AG
Study Sponsor  ICMJE Cereneo AG
Collaborators  ICMJE
  • Swiss Commission for Technology and Innovation
  • Swiss Federal Institute of Technology
  • Hocoma AG
  • University of Zurich
Investigators  ICMJE Not Provided
PRS Account Cereneo AG
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP