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

Primary Purpose

Stroke, Spinal Cord Injury, Healthy

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ARMin
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARMin

Arm Description

Therapy on ARMin robotic device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
muscle strength in Nm
muscle strength will be recorded by the device
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
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
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
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
detection thresholds (time)
Detection thresholds for sensory stimuli will be assessed
detection thresholds (position in cm)
Detection thresholds for sensory stimuli will be assessed

Full Information

First Posted
February 11, 2016
Last Updated
October 7, 2020
Sponsor
Swiss Federal Institute of Technology
Collaborators
Klinik Lengg, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02720341
Brief Title
VIT-ARMin Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin
Acronym
VIT-ARMin
Official Title
Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Doctoral students on project defended their thesis.
Study Start Date
April 10, 2015 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Klinik Lengg, Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injury, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARMin
Arm Type
Experimental
Arm Description
Therapy on ARMin robotic device
Intervention Type
Device
Intervention Name(s)
ARMin
Intervention Description
single sessions of about one hour each
Primary Outcome Measure Information:
Title
Intrinsic Motivation Inventory (IMI) questionaire
Description
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 Outcome Measure Information:
Title
performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec)
Description
kinematic and kinetic data during motor performance will be recorded
Time Frame
within one day
Title
performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm)
Description
kinematic and kinetic data during motor performance will be recorded
Time Frame
within one day
Title
performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm)
Description
kinematic and kinetic data during motor performance will be recorded
Time Frame
within one day
Title
muscle strength in Nm
Description
muscle strength will be recorded by the device
Time Frame
within one day
Title
questionaire on interaction, time and effort
Description
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
Title
EMG for muscle activity (time and electric potential)
Description
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
Time Frame
within one day
Title
EMG for muscle activity (time in sec)
Description
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
Time Frame
within one day
Title
EMG for muscle activity (electric potential in V)
Description
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
Time Frame
within one day
Title
detection thresholds (time)
Description
Detection thresholds for sensory stimuli will be assessed
Time Frame
within one day
Title
detection thresholds (position in cm)
Description
Detection thresholds for sensory stimuli will be assessed
Time Frame
within one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, PhD
Organizational Affiliation
ETH Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus
City
Zürich
ZIP/Postal Code
8002
Country
Switzerland
Facility Name
Balgrist Campus
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
Klinik Lengg
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32024528
Citation
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.
Results Reference
derived
PubMed Identifier
30115082
Citation
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.
Results Reference
derived

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

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