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

Study Overview
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Brief Summary
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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.

Conditions
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Post Stroke Gait Training

Intervention / Treatment
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* Behavioral: Gait training with Lokomat Pro
* Behavioral: Gait training with Lokomat Pro FreeD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lokomat Pro<br>gait robot established on the market | Behavioral: Gait training with Lokomat Pro<br> <br> |
| Experimental: Lokomat Pro FreeD<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |