Post Stroke Gait Training
Conditions
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.
Interventions
BEHAVIORALGait training with Lokomat Pro
BEHAVIORALGait training with Lokomat Pro FreeD
Sponsors
Swiss Commission for Technology and Innovation
Swiss Federal Institute of Technology
Hocoma AG
University of Zurich
Cereneo AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lateral hip movement | 30 min training during day 1 (next session after inclusion) | during 30 min training with each device, lateral hip movements will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 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 | 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). |
Countries
Switzerland
Outcome results
None listed