Strategies of Therapy With the Exoskeleton Robot ARMin

NCT ID: NCT03100422

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-10-31

Brief Summary

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ARMin

Therapy with the arm therapy robot ARMin

Group Type: EXPERIMENTAL

ARMin

Intervention Type: DEVICE

arm therapy robot

Arm+ occupational therapy

a form of conventional occupational therapy that involves both arms

Group Type: ACTIVE_COMPARATOR

Occupational Therapy

Intervention Type: OTHER

bilateral arm training

Interventions

ARMin

arm therapy robot

Intervention Type: DEVICE

Occupational Therapy

bilateral arm training

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rehaklinik Zihlschlacht AG

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Riener, PhD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

Multi VIT-ARMin

Identifier Type: -

Identifier Source: org_study_id