Strategies of Therapy With the Exoskeleton Robot ARMin

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: ARMin; Other: Occupational Therapy

• Registration Number: NCT03100422
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-05-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARMin	ARMin	Therapy with the arm therapy robot ARMin
Arm+ occupational therapy	Occupational Therapy	a form of conventional occupational therapy that involves both arms

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment, upper extremity motor function	from baseline to day 3 post-training	impairment based clinical test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus; 🇨🇭 Zürich, Switzerland