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Completed

NCT Number: NCT03100422

Strategies of Therapy With the Exoskeleton Robot ARMin

Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

Zurich, 8002, Switzerland

About this study

The exoskeleton robot ARMin was further developed and software components adapted accordingly to offer a unique intensified and patient-tailored robot-aided training of the arm. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. The study objective is to compare ARMin therapy and a form of conventional occupational therapy that involves both arms regarding change in motor function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Aged ≥18 years
  • Ischemic cerebral vascular accident (CVA, stroke) in the sub-acute phase (one to twelve weeks post-stroke) as verified by brain imaging (CT or MRI)
  • Inpatient at Rehaklinik Zihlschlacht, Switzerland
  • Decreased arm motor function in one arm with a FMA of 8 to 20 points (out of 66)
  • No excessive spasticity of the affected arm (modified Ashworth Scale mAS ≤3) as assessed by the physician
  • No serious medical or psychiatric disorder as assessed by the physician
  • No serious orthopaedic, rheumatologic or other disease restricting movements of the paretic arm as assessed by the physician
  • No clinically significant shoulder subluxation (palpation <2 fingers) as assessed by the physician
  • No skin ulcerations at the paretic arm as assessed by the physician
  • Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised as assessed by the physician
  • No history of cyber sickness (e.g., nausea when looking at a screen or playing computer games) as assessed by the physician
  • No pacemaker or other implanted electric device as verified by patient record
  • Bodyweight <120 kg
  • No serious cognitive defects or aphasia preventing effective use of ARMin as assessed by the physician

Treatment and study plan

ARMin

Device

arm therapy robot

Occupational Therapy

Other

bilateral arm training

Primary outcomes

  1. Fugl Meyer Assessment, upper extremity motor function

    Time frame: from baseline to day 3 post-training

    impairment based clinical test

Secondary outcomes

  1. ARMin assessment time

    Time frame: from baseline to day 3 post-training

    time

  2. ARMin assessment torques

    Time frame: from baseline to day 3 post-training

    torques

  3. ARMin assessment positions

    Time frame: from baseline to day 3 post-training

    positions

  4. Intrinsic Motivation Inventory

    Time frame: from baseline to day 3 post-training

    questionnaire

  5. Motor Activity Log

    Time frame: from baseline to day 3 post-training

    questionnaire

  6. handheld dynamometer

    Time frame: from baseline to day 3 post-training

    isometric strength

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Rehaklinik Zihlschlacht AG

Registry information

Official study title

Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-ARMin

Acronym: MultiVIT-ARMin

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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