Effect of Personalized Robotic Therapy

Summary

The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force assistance of stroke patients during robotic-rehabilitation.

The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient.

Finally, the study also aims to define the "neuro-biomechanical state" of the patient and its evolution during the therapy by studying cortical signals and muscular synergies. This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient.

The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment. Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment.

Conditions

• Stroke

Interventions

DEVICE

Arm Light Exoskeleton Rehab Station (ALEx RS)

ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress.

DEVICE

Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized

ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress. The movements to be performed by the patient are automatically decided by the exoskeleton.

Sponsors & Collaborators

• University Hospital, Geneva

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Ecole Polytechnique Fédérale de Lausanne

  collaborator OTHER

• Wearable Robotics srl.

  lead INDUSTRY

Principal Investigators

• Adrian Guggisberg, Md · University Hospital, Geneva

• Carmelo Chisari, Md · Azienda Ospedaliera Universitaria Pisana

• Silvestro Micera, Prof. · Ecole Polytechnique Fédérale de Lausanne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Switzerland

Study Locations