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

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

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)

Study Overview

• Status: Terminated
• Conditions: Stroke; Healthy; Spinal Cord Injury
• Intervention / Treatment: Device: ARMin

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 Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Klinik Lengg
  • Zürich, Switzerland, 8002
    • Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus
  • Zürich, Switzerland, 8008
    • Balgrist Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ARMin; Therapy on ARMin robotic device	Device: ARMin; single sessions of about one hour each

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Klinik Lengg, Zurich
• Investigators: Study Chair: Robert Riener, PhD, ETH Zurich

Publications and helpful links

General Publications

• Just F, Ozen O, Tortora S, Klamroth-Marganska V, Riener R, Rauter G. Human arm weight compensation in rehabilitation robotics: efficacy of three distinct methods. J Neuroeng Rehabil. 2020 Feb 5;17(1):13. doi: 10.1186/s12984-020-0644-3.
• Baur K, Speth F, Nagle A, Riener R, Klamroth-Marganska V. Music meets robotics: a prospective randomized study on motivation during robot aided therapy. J Neuroeng Rehabil. 2018 Aug 16;15(1):79. doi: 10.1186/s12984-018-0413-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2015
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (ESTIMATE): March 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Armin
• Other Study ID Numbers: VIT-ARMin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO