Clinical trial NCT03100422: Strategies of Therapy With the Exoskeleton Robot ARMin
Official title: Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-ARMin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Rehaklinik Zihlschlacht AG
First posted: 2017-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl Meyer Assessment, upper extremity motor function
timeFrame: from baseline to day 3 post-training
Secondary outcomes:
measure: ARMin assessment time
timeFrame: from baseline to day 3 post-training
measure: ARMin assessment torques
timeFrame: from baseline to day 3 post-training
measure: ARMin assessment positions
timeFrame: from baseline to day 3 post-training
measure: Intrinsic Motivation Inventory
timeFrame: from baseline to day 3 post-training
measure: Motor Activity Log
timeFrame: from baseline to day 3 post-training
measure: handheld dynamometer
timeFrame: from baseline to day 3 post-training
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus
Study officials:
affiliation: ETH Zurich
name: Robert Riener, PhD
role: PRINCIPAL_INVESTIGATOR
References: