Clinical Trial ROBERT® - Project Active Training

Study Overview
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Brief Summary
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The overall purpose with this clinical trial is to, monitor and secure ROBERT®'s clinical performance and safety in a clinical environment in the regional hospital North Denmark, Neuro Unit North. The purpose of the study is to investigate if ROBERT® has the ability to 1. Perform guided active training. 2. Perform resistance based active training. And validate the safety of ROBERT® in a clinical environment.

Official Title
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Clinical Trial ROBERT® - Project Active Training

Conditions
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Apoplexy; Stroke, Spinal Cord Injuries, Safety, Usability

Intervention / Treatment
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* Device: ROBERT®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalised patients at Neuro Unit North, during the trial period. 18 years or older. Can read, understand and speak Danish Reduced motor function in lower extremities. Exclusion Criteria: No able to sign informed consent. Cannot read, understand or speak Danish Patients with unstable fractures in columna, pelvis or lower extremities. Patients with the risk of ulcers, or with exceedingly sensitive skin. The patient is refusing to train with ROBERT®

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: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training with ROBERT® Passive<br>Training performed with ROBERT® in passive mode, resulting in active assistive training. | Device: ROBERT®<br>* Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.<br>|
| Experimental: Training with ROBERT® Active<br>Traning performed with ROBERT® in Active mode, resulting in active resistive training. | Device: ROBERT®<br>* Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed | Active training capabilities will be assessed, 3 active motions are planned (the therapist has to be active) by the therapist, and manually performed by hand. The resistance perceived by the therapist is then compared to the expert opinion of the therapist to evaluate if this correlates with, small, medium, and large resistance. This is evaluated as passed/not passed for all 3 motions Active assistive training capabilities will be assessed: 3 passive motions are planned (the robot moves, the therapist follows movement), by the therapist and the robot starts performing the motions, the therapist performs a small, moderate and large assistive movement in conjunction with the robot. The results in % of activity in the path of motion are displayed, and the therapist evaluates if this is in agreement with what they would categorise as a small, moderate and large assistive movement respectively. This is evaluated as passed/not passed for all 3 motions. | Up to 19 weeks | 
| Safety, Capture adverse events. | Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions. | Up to 19 weeks |