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

Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: ARMin; Other: Occupational Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8002
    • Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARMin; Therapy with the arm therapy robot ARMin	Device: ARMin; arm therapy robot
Active Comparator: Arm+ occupational therapy; a form of conventional occupational therapy that involves both arms	Other: Occupational Therapy; bilateral arm training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment, upper extremity motor function	impairment based clinical test	from baseline to day 3 post-training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARMin assessment time	time	from baseline to day 3 post-training
ARMin assessment torques	torques	from baseline to day 3 post-training
ARMin assessment positions	positions	from baseline to day 3 post-training
Intrinsic Motivation Inventory	questionnaire	from baseline to day 3 post-training
Motor Activity Log	questionnaire	from baseline to day 3 post-training
handheld dynamometer	isometric strength	from baseline to day 3 post-training

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Rehaklinik Zihlschlacht AG
• Investigators: Principal Investigator: Robert Riener, PhD, ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Armin
• Other Study ID Numbers: Multi VIT-ARMin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No