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Strategies of Therapy With the Exoskeleton Robot ARMin (MultiVIT-ARMin)

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Stroke

Treatments

Other: Occupational Therapy
Device: ARMin

Study type

Interventional

Funder types

Other

Identifiers

NCT03100422
Multi VIT-ARMin

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 2 patient groups

ARMin
Experimental group
Description:
Therapy with the arm therapy robot ARMin
Treatment:
Device: ARMin
Arm+ occupational therapy
Active Comparator group
Description:
a form of conventional occupational therapy that involves both arms
Treatment:
Other: Occupational Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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