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

Not Applicable

Terminated

• Conditions: Stroke; Spinal Cord Injury; Healthy
• Interventions: Device: ARMin

• Registration Number: NCT02720341
• Lead Sponsor: Swiss Federal Institute of Technology

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

Study Timeline

• Study Start: 2015-04-10
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 222

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARMin	ARMin	Therapy on ARMin robotic device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
detection thresholds (time)	within one day	Detection thresholds for sensory stimuli will be assessed
muscle strength in Nm	within one day	muscle strength will be recorded by the device
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
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
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
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
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
detection thresholds (position in cm)	within one day	Detection thresholds for sensory stimuli will be assessed

Trial Locations

Locations (3)

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus; 🇨🇭 Zürich, Switzerland

Balgrist Campus; 🇨🇭 Zürich, Switzerland

Klinik Lengg; 🇨🇭 Zürich, Switzerland