VIT-ARMin Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-10

Study Completion Date

2020-07-31

Brief Summary

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Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke, spinal cord injury)

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Detailed Description

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Neurological patients (e.g., after stroke) need long-term neurorehabilitative therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitative training. Investigators aim at developing a unique intensified and patient-tailored robot-aided training strategy of the arm. The exoskeleton robot ARMin will be further developed to adapt software components accordingly. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. It can be intensified by different strategies that will be evaluated alone and in combination. These strategies include:

strength training an error-amplification strategy increased number of repetitions multisensory feedback multiplayer approach

Conditions

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Stroke Spinal Cord Injury Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARMin

Therapy on ARMin robotic device

Group Type EXPERIMENTAL

ARMin

Intervention Type DEVICE

single sessions of about one hour each

Interventions

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ARMin

single sessions of about one hour each

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

healthy or CVA or spinal cord injury

* Aged ≥18 years
* No excessive spasticity of the affected arm (modified Ashworth Scale ≤3)
* No serious medical or psychiatric disorder as assessed by their physician
* No orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
* No shoulder subluxation (palpation \<2 fingers)
* No skin ulcerations at the paretic arm
* Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised
* No cybersickness (e.g., nausea when looking at a screen or playing computer games)
* No pacemaker or other implanted electric devices
* Bodyweight \<120 kg
* No serious cognitive defects or aphasia preventing effective use of ARMin