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

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ClinicalTrials.gov Identifier: NCT02720341
Recruitment Status : Terminated (Doctoral students on project defended their thesis.)
First Posted : March 25, 2016
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Klinik Lengg, Zurich
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Stroke Spinal Cord Injury Healthy Device: ARMin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin
Actual Study Start Date : April 10, 2015
Actual Primary Completion Date : July 2020
Actual Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: ARMin
Therapy on ARMin robotic device
Device: ARMin
single sessions of about one hour each




Primary Outcome Measures :
  1. Intrinsic Motivation Inventory (IMI) questionaire [ Time Frame: 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 :
  1. performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec) [ Time Frame: within one day ]
    kinematic and kinetic data during motor performance will be recorded

  2. performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm) [ Time Frame: within one day ]
    kinematic and kinetic data during motor performance will be recorded

  3. performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm) [ Time Frame: within one day ]
    kinematic and kinetic data during motor performance will be recorded

  4. muscle strength in Nm [ Time Frame: within one day ]
    muscle strength will be recorded by the device

  5. questionaire on interaction, time and effort [ Time Frame: 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

  6. EMG for muscle activity (time and electric potential) [ Time Frame: 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

  7. EMG for muscle activity (time in sec) [ Time Frame: 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

  8. EMG for muscle activity (electric potential in V) [ Time Frame: 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

  9. detection thresholds (time) [ Time Frame: within one day ]
    Detection thresholds for sensory stimuli will be assessed

  10. detection thresholds (position in cm) [ Time Frame: within one day ]
    Detection thresholds for sensory stimuli will be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720341


Locations
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Switzerland
Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus
Zürich, Switzerland, 8002
Balgrist Campus
Zürich, Switzerland, 8008
Klinik Lengg
Zürich, Switzerland, 8008
Sponsors and Collaborators
Swiss Federal Institute of Technology
Klinik Lengg, Zurich
Investigators
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Study Chair: Robert Riener, PhD ETH Zurich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02720341    
Other Study ID Numbers: VIT-ARMin
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Armin
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs