VIT-ARMin Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin

Study Overview
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Brief Summary
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Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke, spinal cord injury)

Detailed Description
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Neurological patients (e.g., after stroke) need long-term neurorehabilitative therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitative training. Investigators aim at developing a unique intensified and patient-tailored robot-aided training strategy of the arm. The exoskeleton robot ARMin will be further developed to adapt software components accordingly. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. It can be intensified by different strategies that will be evaluated alone and in combination. These strategies include: strength training an error-amplification strategy increased number of repetitions multisensory feedback multiplayer approach

Official Title
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Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin

Conditions
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Stroke, Spinal Cord Injury, Healthy

Intervention / Treatment
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* Device: ARMin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy or CVA or spinal cord injury Aged ≥18 years No excessive spasticity of the affected arm (modified Ashworth Scale ≤3) No serious medical or psychiatric disorder as assessed by their physician No orthopaedic, rheumatological, or other disease restricting movements of the paretic arm No shoulder subluxation (palpation <2 fingers) No skin ulcerations at the paretic arm Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised No cybersickness (e.g., nausea when looking at a screen or playing computer games) No pacemaker or other implanted electric devices Bodyweight <120 kg No serious cognitive defects or aphasia preventing effective use of ARMin Exclusion Criteria - Allergy against alcohol or no agreement for skin shaving

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARMin<br>Therapy on ARMin robotic device | Device: ARMin<br>* single sessions of about one hour each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrinsic Motivation Inventory (IMI) questionaire | The IMI is a multidimensional measurement device that assesses participants' interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity, thus yielding six subscale scores | within one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec) | kinematic and kinetic data during motor performance will be recorded | within one day | 
| performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm) | kinematic and kinetic data during motor performance will be recorded | within one day | 
| performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm) | kinematic and kinetic data during motor performance will be recorded | within one day | 
| muscle strength in Nm | muscle strength will be recorded by the device | within one day | 
| questionaire on interaction, time and effort | questions rated on a analog scale by the participant regarding the interaction with participants and therapists, the perceived time and the perceived effort | within one day | 
| EMG for muscle activity (time and electric potential) | The level of muscular activity will be assessed by surface electromyography (EMG). The EMG device to be employed is a wireless commercially available certified device (Noraxon). EMG activity of different shoulder and elbow muscles will be recorded using surface electrodes to compare muscle activations in different muscles | within one day | 
| EMG for muscle activity (time in sec) | The level of muscular activity will be assessed by surface electromyography (EMG). The EMG device to be employed is a wireless commercially available certified device (Noraxon). EMG activity of different shoulder and elbow muscles will be recorded using surface electrodes to compare muscle activations in different muscles | within one day | 
| EMG for muscle activity (electric potential in V) | The level of muscular activity will be assessed by surface electromyography (EMG). The EMG device to be employed is a wireless commercially available certified device (Noraxon). EMG activity of different shoulder and elbow muscles will be recorded using surface electrodes to compare muscle activations in different muscles | within one day | 
| detection thresholds (time) | Detection thresholds for sensory stimuli will be assessed | within one day | 
| detection thresholds (position in cm) | Detection thresholds for sensory stimuli will be assessed | within one day |