Healthy, Spinal Cord Injury, Stroke
Conditions
Brief summary
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
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
Interventions
DEVICEARMin
single sessions of about one hour each
Sponsors
Klinik Lengg, Zurich
Swiss Federal Institute of Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrinsic Motivation Inventory (IMI) questionaire | within one day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm) | within one day | kinematic and kinetic data during motor performance will be recorded |
| performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm) | within one day | kinematic and kinetic data during motor performance will be recorded |
| muscle strength in Nm | within one day | muscle strength will be recorded by the device |
| questionaire on interaction, time and effort | within one day | questions rated on a analog scale by the participant regarding the interaction with participants and therapists, the perceived time and the perceived effort |
| performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec) | within one day | kinematic and kinetic data during motor performance will be recorded |
| EMG for muscle activity (time in sec) | within one day | 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 |
| EMG for muscle activity (electric potential in V) | within one day | 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 |
| detection thresholds (time) | within one day | Detection thresholds for sensory stimuli will be assessed |
| detection thresholds (position in cm) | within one day | Detection thresholds for sensory stimuli will be assessed |
| EMG for muscle activity (time and electric potential) | within one day | 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 |
Countries
Switzerland
Outcome results
None listed