Post StrokeReHybNCT07270484
Rehabilitation Based on Hybrid Neuroprosthesis
A study testing ReHyb-HPP and ReHyb-LPP in people with Post Stroke, run by Villa Beretta Rehabilitation Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke
- What is being tested?
- ReHyb-HPP and ReHyb-LPP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Feb 2024to 24 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- No written informed consent from the patient or the legal representative
- Active implantable devices (e.g., pacemaker)
- Unstable medical condition
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Rehabilitation Based on Hybrid Neuroprosthesis: Evaluation of the Feasibility, Functionality and Usability of the System in a Post-stroke Patient Population.
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.
Read the detailed description
The ReHyb project, being oriented towards the development of a hybrid, modular, flexible and patient-specific upper-body hybrid neuro-prosthesis, potentially able to maximize the training efficacy during hospital stay as well as home-based rehabilitation or assistance during Activities of Daily Living (ADL), offering at the same time a pleasant user experience, has led to the development and integration of different modules in an attempt to adapt to the specific conditions of different patients. This goal has oriented the Consortium toward a participatory design (PD) and an ethics-by-design approach (EbD) that has been applied all along the execution of the project.
Under this perspective, two platforms have been developed and evaluated according to the following:
- Evaluation of platforms: The global evaluation of the ReHyb system and its two developed platforms, High Power Platform (HPP) and Low Power Platform (LPP). To meet this goal, a pilot, multicenter, prospective, and open study was defined to test feasibility, functionality and usability of the two platforms that constitute the hybrid neuro-prosthesis developed. A total of 24 post-stroke patients (12 per clinical site) were recruited during a time-span of 12 months for the evaluation of the ReHyb system. This number was considered sufficient for the statistical analysis to investigate the feasibility and usability of the platforms. Furthermore, the sample size is expected to allow for finding most of the usability problems.
When evaluating the ReHyb platforms in full and in their different module combinations, the ReHyb project has incorporated two different hardware devices: a stationary high powered device (ReHyb-HP) and a portable spring-loaded device (ReHyb-SL), which are both integrated with FES support. The software components include the control algorithms of the platforms, a training environment (e.g., the Rehabilitations Gaming System (RGS), a desktop Virtual Reality (VR) setup with gamified protocols for motor and cognitive rehabilitation), and the Digital Twin (e.g., the level of task difficulty and the amount of support will be adapted to the capabilities of the user).
The general scope of the studies herein presented is about evaluating the developed ReHyb System regarding its feasibility, functionality and usability rather than about evaluating any therapeutic effect of using the device. As a consequence, with a maximum duration of 3 weeks and five sessions of training per subject, the study participation is probably not long enough to expect therapeutic effects induced by the hybrid training. In fact, in previous studies, a minimum of four to seven weeks of intervention was required to detect significant clinical improvements in upper limb functions.
The applied clinical investigation protocol (CIP) was the same for the two clinical rehabilitation centres namely: Schön Klinik (SK) and VALDUCE. Nevertheless, some minimal differences were registered between the two centres without major impact on the results obtained, but with interesting complementary information coming from some of the main stakeholders on the use of the new integrated devices. In particular, SK has included the evaluation made by healthcare operators and caregivers, who have been considered the closest stakeholders to patients involved in the study.
- Conditions
- Post Stroke
- Being tested
- ReHyb-HPP, ReHyb-LPP
- Keywords
- post stroke, Rehabilitation, Robobotics, Hybrid, Exoskeleton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReHyb-HPPDevice
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-LPPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ReHyb-LPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: 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.
Measured: 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.
Measured: from enrollment to end of treatment (up to 2 weeks).
Usability
Usability is assessed with donning and doffing time (measured in minutes).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Day 6
Usability
Patient satisfaction with the device was assessed with Outcome of Prosthesis Use Survey (OPUS). The scale ranges from 0-100.
Measured: Day 6
Secondary outcomes (2)
Assistive Torques
Functionality of the platform is assessed with performance of the designed assistive algorithms, and their correct functioning, namely average torques provided (measured in Nm) across sessions.
Measured: From enrollment to the end of treatment (up to two weeks)
Assistance Stimulation currents
Functionality of the platform is assessed with performance of the designed assistive algorithms, and their correct functioning, namely , average stimulation currents (measured in mA) across session.
Measured: Throughout the delivered therapy (up to two weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start12 Feb 2024
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Beretta Rehabilitation Center
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Össur Iceland ehf, Imperial College London, Technical University of Denmark, Schoen Clinic Bad Aibling, Radboud University, The Netherlands, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, IUVO S.r.l., Tecnalia
- Responsible party
- Principal investigator, Dr. Franco Molteni, Villa Beretta Rehabilitation Center
- Investigators
- Franco Molteni, Medical Doctor, Principal investigator, Villa Beretta Rehabilitation CenterKlaus Jahn, Medical Doctor, Principal investigator, Schon Klinik Bad Aibling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270484
- Sponsor's protocol ID
- 871767
- Acronym
- ReHyb
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Based on Hybrid Neuroprosthesis: Evaluation of the Feasibility, Functionality and Usability of the System in a Post-stroke Patient Population.
- ClinicalTrials.gov ID
- NCT07270484
- Acronym / sponsor ID
- ReHyb / 871767
- Conditions
- Post Stroke
- Keywords
- post stroke, Rehabilitation, Robobotics, Hybrid, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Villa Beretta Rehabilitation CenterUniversity, hospital or other
- Collaborators
- Technical University of Munich, Össur Iceland ehf, Imperial College London, Technical University of Denmark, Schoen Clinic Bad Aibling, Radboud University, The Netherlands, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, IUVO S.r.l., Tecnalia
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ReHyb project, being oriented towards the development of a hybrid, modular, flexible and patient-specific upper-body hybrid neuro-prosthesis, potentially able to maximize the training efficacy during hospital stay as well as home-based rehabilitation or assistance during Activities of Daily Living (ADL), offering at the same time a pleasant user experience, has led to the development and integration of different modules in an attempt to adapt to the specific conditions of different patients. This goal has oriented the Consortium toward a participatory design (PD) and an ethics-by-design approach (EbD) that has been applied all along the execution of the project.
Under this perspective, two platforms have been developed and evaluated according to the following:
- Evaluation of platforms: The global evaluation of the ReHyb system and its two developed platforms, High Power Platform (HPP) and Low Power Platform (LPP). To meet this goal, a pilot, multicenter, prospective, and open study was defined to test feasibility, functionality and usability of the two platforms that constitute the hybrid neuro-prosthesis developed. A total of 24 post-stroke patients (12 per clinical site) were recruited during a time-span of 12 months for the evaluation of the ReHyb system. This number was considered sufficient for the statistical analysis to investigate the feasibility and usability of the platforms. Furthermore, the sample size is expected to allow for finding most of the usability problems.
When evaluating the ReHyb platforms in full and in their different module combinations, the ReHyb project has incorporated two different hardware devices: a stationary high powered device (ReHyb-HP) and a portable spring-loaded device (ReHyb-SL), which are both integrated with FES support. The software components include the control algorithms of the platforms, a training environment (e.g., the Rehabilitations Gaming System (RGS), a desktop Virtual Reality (VR) setup with gamified protocols for motor and cognitive rehabilitation), and the Digital Twin (e.g., the level of task difficulty and the amount of support will be adapted to the capabilities of the user).
The general scope of the studies herein presented is about evaluating the developed ReHyb System regarding its feasibility, functionality and usability rather than about evaluating any therapeutic effect of using the device. As a consequence, with a maximum duration of 3 weeks and five sessions of training per subject, the study participation is probably not long enough to expect therapeutic effects induced by the hybrid training. In fact, in previous studies, a minimum of four to seven weeks of intervention was required to detect significant clinical improvements in upper limb functions.
The applied clinical investigation protocol (CIP) was the same for the two clinical rehabilitation centres namely: Schön Klinik (SK) and VALDUCE. Nevertheless, some minimal differences were registered between the two centres without major impact on the results obtained, but with interesting complementary information coming from some of the main stakeholders on the use of the new integrated devices. In particular, SK has included the evaluation made by healthcare operators and caregivers, who have been considered the closest stakeholders to patients involved in the study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rehyb Device: High-Powered Platform | Experimental | Device: ReHyb-HPPPatients 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. |
| ReHyb Device: Low-Powered Platform | Experimental | Device: ReHyb-LPPPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReHyb-HPPUp 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 Device: High-Powered Platform |
| ReHyb-LPPUp 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. | Device | ReHyb Device: Low-Powered Platform |
Primary outcome
Feasibility score
Time frame: Day3 and Day5
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),
Usability
Time frame: Day 6
Perceived Usability of the device from the patients perspective. Assessed with System Usability Scale (SUS) scale questionnaire. The scale ranges from 0-100.
Number of adverse Events
Time frame: from enrollment to end of treatment (up to 2 weeks).
Safety of the delivered treatment is assessed monitoring the number of Adverse Event (AE). The metric is the number of events.
Usability
Time frame: Throughout the delivered treatment (up to 2 weeks).
Usability is assessed with donning and doffing time (measured in minutes).
Feasibility score
Time frame: Day 3 and Day 5
Feasibility score of the treatment is assessed through Intrinsic Motivation Inventory (IMI, 1-7 on a likert scale per each item)
Usability
Time frame: Day 3 and Day 5
Usability from the patient's perspective i evaluated with the Flow State Scale (FSS, 1-7 on a likert scale per each item)
Feasibiliy
Time frame: Day 3 and Day 5
Feasibiliy is evaluated with the User Experience Questionnaire (UEQ, -3 to 3 on a likert scale per each item) - short.
Usability
Time frame: Day 6
Perceived physical and cognitive fatigue were assessed with NASA-Task Load index (NASA-TLX). The scale ranges from 0-100.
Usability
Time frame: Day 6
Patient satisfaction with the device was assessed with Outcome of Prosthesis Use Survey (OPUS). The scale ranges from 0-100.
2 secondary outcomes
Assistive Torques
Time frame: From enrollment to the end of treatment (up to two weeks)
Assistance Stimulation currents
Time frame: Throughout the delivered therapy (up to two weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Molteni, Medical Doctor principal investigator
Villa Beretta Rehabilitation Center
Klaus Jahn, Medical Doctor principal investigator
Schon Klinik Bad Aibling
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReHyb-HPP and ReHyb-LPP in people with Post Stroke, run by Villa Beretta Rehabilitation Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility score (time frame: Day3 and Day5). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.