Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2024-02-12
2024-05-24
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Rehyb Device: High-Powered Platform
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.
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.
ReHyb Device: Low-Powered Platform
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Össur Iceland ehf
INDUSTRY
Imperial College London
OTHER
Technical University of Denmark
OTHER
Schoen Clinic Bad Aibling
OTHER
Radboud University, The Netherlands
UNKNOWN
Scuola Superiore Sant'Anna di Pisa
OTHER
IUVO S.r.l.
INDUSTRY
Tecnalia
UNKNOWN
Villa Beretta Rehabilitation Center
OTHER
Responsible Party
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Dr. Franco Molteni
Medical Doctor
Principal Investigators
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Franco Molteni, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Villa Beretta Rehabilitation Center
Klaus Jahn, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Schon Klinik Bad Aibling
Locations
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Schon Klinik
Bad Aibling, , Germany
Villa Beretta Rehabilitation Center
Costa Masnaga, Lecco, Italy
Countries
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Other Identifiers
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871767
Identifier Type: -
Identifier Source: org_study_id