Strategies of Therapy With the Exoskeleton Robot ARMin

Study Overview
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Brief Summary
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Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training.

Detailed Description
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The exoskeleton robot ARMin was further developed and software components adapted accordingly to offer a unique intensified and patient-tailored robot-aided training of the arm. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. The study objective is to compare ARMin therapy and a form of conventional occupational therapy that involves both arms regarding change in motor function.

Official Title
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Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-ARMin

Conditions
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Stroke

Intervention / Treatment
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* Device: ARMin
* Other: Occupational Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Aged ≥18 years Ischemic cerebral vascular accident (CVA, stroke) in the sub-acute phase (one to twelve weeks post-stroke) as verified by brain imaging (CT or MRI) Inpatient at Rehaklinik Zihlschlacht, Switzerland Decreased arm motor function in one arm with a FMA of 8 to 20 points (out of 66) No excessive spasticity of the affected arm (modified Ashworth Scale mAS ≤3) as assessed by the physician No serious medical or psychiatric disorder as assessed by the physician No serious orthopaedic, rheumatologic or other disease restricting movements of the paretic arm as assessed by the physician No clinically significant shoulder subluxation (palpation <2 fingers) as assessed by the physician No skin ulcerations at the paretic arm as assessed by the physician Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised as assessed by the physician No history of cyber sickness (e.g., nausea when looking at a screen or playing computer games) as assessed by the physician No pacemaker or other implanted electric device as verified by patient record Bodyweight <120 kg No serious cognitive defects or aphasia preventing effective use of ARMin as assessed by the physician

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARMin<br>Therapy with the arm therapy robot ARMin | Device: ARMin<br>* arm therapy robot<br>|
| Active Comparator: Arm+ occupational therapy<br>a form of conventional occupational therapy that involves both arms | Other: Occupational Therapy<br>* bilateral arm training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Assessment, upper extremity motor function | impairment based clinical test | from baseline to day 3 post-training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARMin assessment time | time | from baseline to day 3 post-training | 
| ARMin assessment torques | torques | from baseline to day 3 post-training | 
| ARMin assessment positions | positions | from baseline to day 3 post-training | 
| Intrinsic Motivation Inventory | questionnaire | from baseline to day 3 post-training | 
| Motor Activity Log | questionnaire | from baseline to day 3 post-training | 
| handheld dynamometer | isometric strength | from baseline to day 3 post-training |