Study Stopped
an additional intervention, amendet to the study (3rd arm, not described here), has not received clearance by regulatory authorities
Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System
LOKOMAT
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedAugust 15, 2018
August 1, 2018
8 months
June 30, 2014
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Lateral hip movement
during 30 min training with each device, lateral hip movements will be assessed
30 min training during day 1 (next session after inclusion)
Secondary Outcomes (2)
Patient satisfaction
day 2 and 3
Patient motivation
day 2 and 3
Study Arms (2)
Lokomat Pro
ACTIVE COMPARATORgait robot established on the market
Lokomat Pro FreeD
EXPERIMENTALgait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market
Interventions
Eligibility Criteria
You may qualify if:
- Lower extremity weakness due to stroke
- minor functional impairment (MRC \< 5)
- ability and willingness to participate
You may not qualify if:
- severe spasticity of the lower extremities
- severe dementia
- severe depression
- any other contraindications against Lokomat training
- body weight \> 135 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cereneo AGlead
- Swiss Commission for Technology and Innovationcollaborator
- Swiss Federal Institute of Technologycollaborator
- Hocoma AGcollaborator
- University of Zurichcollaborator
Study Sites (1)
Cereneo, Center For Rehabilitation and Neurology
Vitznau, Canton of Lucerne, 6354, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 14, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
August 15, 2018
Record last verified: 2018-08