Rehabilitation Based on Hybrid Neuroprosthesis (ReHyb)

Villa Beretta Rehabilitation Center

Status: Completed

Conditions: Post Stroke

Treatments: Device: ReHyb-HPP; Device: ReHyb-LPP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07270484

871767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Rehyb Device: High-Powered Platform

Experimental group

Description:

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.

Treatment:

Device: ReHyb-HPP

ReHyb Device: Low-Powered Platform

Experimental group

Description:

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.

Treatment:

Device: ReHyb-LPP