Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System (LOKOMAT)
|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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|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|
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
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189551
|Cereneo, Center For Rehabilitation and Neurology|
|Vitznau, LU, Switzerland, 6354|