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

N/ATerminatedNCT02720341

Swiss Federal Institute of Technology222 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

222

Conditions

Stroke Spinal Cord Injury Healthy

Interventions

ARMinDEVICE

single sessions of about one hour each

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

Zurich, Switzerland

Balgrist Campus

Zurich, Switzerland

Klinik Lengg

Zurich, Switzerland

Outcomes

Primary Outcomes

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

Time frame: within one day

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: within one day

muscle strength in Nm

muscle strength will be recorded by the device

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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