NCT02720341

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

5.2 years

First QC Date

February 11, 2016

Last Update Submit

October 7, 2020

Conditions

StrokeSpinal Cord InjuryHealthy

Outcome Measures

Primary Outcomes (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

    within one day

Secondary Outcomes (10)

  • performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec)

    within one day

  • performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm)

    within one day

  • performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm)

    within one day

  • muscle strength in Nm

    within one day

  • questionaire on interaction, time and effort

    within one day

  • +5 more secondary outcomes

Study Arms (1)

ARMin

EXPERIMENTAL

Therapy on ARMin robotic device

Device: ARMin

Interventions

ARMinDEVICE

single sessions of about one hour each

ARMin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Allergy against alcohol or no agreement for skin shaving

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

Zurich, 8002, Switzerland

Location

Balgrist Campus

Zurich, 8008, Switzerland

Location

Klinik Lengg

Zurich, 8008, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 39905053DERIVED

  • 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.

    PMID: 32024528DERIVED

  • 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.

    PMID: 30115082DERIVED

MeSH Terms

Conditions

StrokeSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Robert Riener, PhD

    ETH Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

March 25, 2016

Study Start

April 10, 2015

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(3)