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an additional intervention, amendet to the study (3rd arm, not described here), has not received clearance by regulatory authorities
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| Name | Class |
|---|---|
| Swiss Commission for Technology and Innovation | OTHER |
| Swiss Federal Institute of Technology | OTHER |
| Hocoma AG | UNKNOWN |
| University of Zurich |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat Pro | Active Comparator | gait robot established on the market |
|
| Lokomat Pro FreeD | Experimental | gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait training with Lokomat Pro | Behavioral |
| ||
| Gait training with Lokomat Pro FreeD |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cereneo, Center For Rehabilitation and Neurology | Vitznau | Canton of Lucerne | 6354 | Switzerland |
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| OTHER |
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| Behavioral |
|
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 |