Rehabilitation Based on Hybrid Neuroprosthesis

Summary

The study is a pilot, multi-center, prospective, and open study to test feasibility, functionality and usability of a device defined as a hybrid neuroprosthesis.

Conditions

• Post Stroke

Interventions

DEVICE

ReHyb-HPP

Up to 7 sessions lasting approximately 60 minutes will be carried out, including dressing and undressing the exoskeleton and/or electrodes. At the end of the third and fifth training sessions, some questionnaires will be administered. At the end of each training session, the patient's adherence to the selected platform configuration will be reassessed and modified as appropriate to ensure the subject's comfort and, at the same time, to evaluate the platform's adaptability to the subject's specific conditions. Together with Functional electrical stimulation, patients received active assistance during predefined repetitive movements of the upper limb playing a single game.

DEVICE

ReHyb-LPP

Up to 7 sessions lasting approximately 60 minutes will be carried out, including dressing and undressing the exoskeleton and/or electrodes. At the end of the third and fifth training sessions, some questionnaires will be administered. At the end of each training session, the patient's adherence to the selected platform configuration will be reassessed and modified as appropriate to ensure the subject's comfort and, at the same time, to evaluate the platform's adaptability to the subject's specific conditions. Together with Functional electrical stimulation, patients received passive assistance only at the shoulder level, during unstructured movements of the upper limb playing games with adaptive difficulty.

Sponsors & Collaborators

• Technical University of Munich

  collaborator OTHER

• Össur Iceland ehf

  collaborator INDUSTRY

• Imperial College London

  collaborator OTHER

• Technical University of Denmark

  collaborator OTHER

• Schoen Clinic Bad Aibling

  collaborator OTHER

• Radboud University, The Netherlands

  collaborator UNKNOWN

• Scuola Superiore Sant'Anna di Pisa

  collaborator OTHER

• IUVO S.r.l.

  collaborator INDUSTRY

• Tecnalia

  collaborator UNKNOWN

• Villa Beretta Rehabilitation Center

  lead OTHER

Principal Investigators

• Franco Molteni, Medical Doctor · Villa Beretta Rehabilitation Center

• Klaus Jahn, Medical Doctor · Schon Klinik Bad Aibling

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-12

Primary Completion

2024-05-24

Completion

2024-05-24

Countries

• Germany
• Italy

Study Locations