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StrokeVIT-ARMinNCT02720341

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

A study testing ARMin in people with Stroke and Spinal Cord Injury, run by Swiss Federal Institute of Technology at 3 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke, Spinal Cord Injury, Healthy
What is being tested?
ARMin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
3 sitesSwitzerland
Study dates
10 Apr 2015to Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • Allergy against alcohol or no agreement for skin shaving

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

    Zurich, 8002

  • Balgrist Campus

    Zurich, 8008

  • Klinik Lengg

    Zurich, 8008

Other trials in Switzerland

About this study

Official title: 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)

Read the 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

Being tested
ARMin
Medical subject headings
Stroke, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARMinDevice

    single sessions of about one hour each

Study groups in NCT02720341
Study groupRoleWhat they receive
ARMinExperimentalTherapy on ARMin robotic device
Receives: Device: ARMin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: within one day

Secondary outcomes (10)

  1. 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

    Measured: within one day

  2. 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

    Measured: within one day

  3. 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

    Measured: within one day

  4. muscle strength in Nm

    muscle strength will be recorded by the device

    Measured: within one day

  5. 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

    Measured: within one day

  6. 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

    Measured: within one day

  7. 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

    Measured: within one day

  8. 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

    Measured: within one day

  9. detection thresholds (time)

    Detection thresholds for sensory stimuli will be assessed

    Measured: within one day

  10. detection thresholds (position in cm)

    Detection thresholds for sensory stimuli will be assessed

    Measured: within one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study start10 Apr 2015
  3. Primary completionJul 2020
  4. Study completionJul 2020

Why it stopped: Doctoral students on project defended their thesis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720341
Sponsor's protocol ID
VIT-ARMin
Acronym
VIT-ARMin
Status last verified
Oct 2020
First submitted
11 Feb 2016
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Aghamohammadi NR, Bittmann MF, Klamroth-Marganska V, Riener R, Huang FC, Patton JL. Error fields: personalized robotic movement training that augments one's more likely mistakes. Sci Rep. 2025 Feb 4;15(1):4201. doi: 10.1038/s41598-025-87331-x.

    PubMed 39905053

  • 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.

    PubMed 32024528

  • 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.

    PubMed 30115082

Questions about this trial

What is this clinical trial studying?

A study testing ARMin in people with Stroke and Spinal Cord Injury, run by Swiss Federal Institute of Technology at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Doctoral students on project defended their thesis.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrinsic Motivation Inventory (IMI) questionaire (time frame: within one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720341, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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