Rehabilitation Based on Hybrid Neuroprosthesis

NCT07270484 | Completed

• 1 other identifier: 871767
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

post stroke; Rehabilitation; Robobotics; Hybrid; Exoskeleton

Outcome Measures

Primary Outcomes (9)

• Feasibility score

  Feasibility score is assessed by means of Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT, 1-7on a likert scale per each item),

  Day3 and Day5

• Usability

  Perceived Usability of the device from the patients perspective. Assessed with System Usability Scale (SUS) scale questionnaire. The scale ranges from 0-100.

  Day 6

• Number of adverse Events

  Safety of the delivered treatment is assessed monitoring the number of Adverse Event (AE). The metric is the number of events.

  from enrollment to end of treatment (up to 2 weeks).

• Usability

  Usability is assessed with donning and doffing time (measured in minutes).

  Throughout the delivered treatment (up to 2 weeks).

• Feasibility score

  Feasibility score of the treatment is assessed through Intrinsic Motivation Inventory (IMI, 1-7 on a likert scale per each item)

  Day 3 and Day 5

• Usability

  Usability from the patient's perspective i evaluated with the Flow State Scale (FSS, 1-7 on a likert scale per each item)

  Day 3 and Day 5

• Feasibiliy

  Feasibiliy is evaluated with the User Experience Questionnaire (UEQ, -3 to 3 on a likert scale per each item) - short.

  Day 3 and Day 5

• Usability

  Perceived physical and cognitive fatigue were assessed with NASA-Task Load index (NASA-TLX). The scale ranges from 0-100.

  Day 6

• Usability

  Patient satisfaction with the device was assessed with Outcome of Prosthesis Use Survey (OPUS). The scale ranges from 0-100.

  Day 6

Secondary Outcomes (2)

• Assistive Torques

  From enrollment to the end of treatment (up to two weeks)

• Assistance Stimulation currents

  Throughout the delivered therapy (up to two weeks).

Study Arms (2)

Rehyb Device: High-Powered Platform

EXPERIMENTAL

Patients with lower residual mobility were assigned to the High-Powered platform (ReHyb-HPP). Patients assigned to ReHyb-HPP received upper limb mobilization, with active assistance, and Functional Electrical Stimulation.

Device: ReHyb-HPP

ReHyb Device: Low-Powered Platform

EXPERIMENTAL

Patients with higher residual mobility were assigned to the Low-Powered platform (ReHyb-LPP). Patients assigned to ReHyb-LPP received upper limb mobilization, with passive assistance, and Functional Electrical Stimulation.

Device: ReHyb-LPP

Interventions

ReHyb-HPP DEVICE

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.

Rehyb Device: High-Powered Platform

ReHyb-LPP DEVICE

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.

ReHyb Device: Low-Powered Platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (women or men aged ≥ 18 years)
• with a diagnosis of stroke either hemorrhagic or ischemic
• with a hemiparesis of the upper limb (0 ≤ MRC ≤ 4)
• in sub-acute (up to six months after acute event) or chronic condition (more than 6 months from the acute event).
• Able to sit upright for the duration of the test.
• Subjects with a level of cognitive capacity that enables him/her to follow the instructions related to the performance of exercises.

You may not qualify if:

• Subjects with a high level of spasticity (Modified Ashworth Scale: In general \>3 except for motorized joints which may be \>2)
• Pain in the affected upper limb (Numeric Rating Scale \> 4)
• Severe psychiatric disorder
• Permanent neurological symptoms present immediately before stroke
• Physical conditions that can alter normal biomechanics (e.g., recent sprains or injuries, etc.)
• Pregnant or nursing women
• No written informed consent from the patient or the legal representative
• Active implantable devices (e.g., pacemaker)
• Unstable medical condition

Sponsors & Collaborators

• Schoen Clinic Bad Aibling: collaborator
• Radboud University, The Netherlands: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator
• IUVO S.r.l.: collaborator
• Tecnalia: collaborator
• Villa Beretta Rehabilitation Center: lead
• Technical University of Munich: collaborator
• Össur Iceland ehf: collaborator
• Imperial College London: collaborator
• Technical University of Denmark: collaborator

Study Sites (2)

Schon Klinik

Bad Aibling, 83043, Germany

Location

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

Location

Study Officials

• Franco Molteni, Medical Doctor

  Villa Beretta Rehabilitation Center

  PRINCIPAL INVESTIGATOR

• Klaus Jahn, Medical Doctor

  Schon Klinik Bad Aibling

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 6 patients per platform in each clinical site were enrolled. This led to a total sample size of 24 patients. The 24 patients defined as the sample size was considered appropriate for feasibility evaluation since the system was composed by two different platforms related to the different needs patients may have according to their clinical conditions.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: December 8, 2025
• Study Start: February 12, 2024
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

DE (1); IT (1)