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Rehabilitation based on hybrid neuroprosthesis: Evaluation of the feasibility, functionality, and usability of the system in post-stroke patient population

Rehabilitation based on hybrid neuroprosthesis: Evaluation of the feasibility, functionality, and usability of the system in post-stroke patient population - ReHyb

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033115
Enrollment
24
Registered
2023-12-01
Start date
2023-12-05
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paresis of the upper extremity due to ischemic or hemorrhagic stroke I61 I63 I64

Interventions

Group 1: In the one-arm pilot trial, all subjects completed five serious gaming sessions with the hybrid neuroprosthesis. Before the first therapy session, comprehensive clinical examinations are carr

Sponsors

Schön Klinik Bad Aibling SE & Co. KG
Lead Sponsor
Congregazione Suore Infermiere dell' Addolorata - Ospedale Valduce
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - diagnosis of stroke (hemorrhagic or ischemic) - hemiparesis of the upper limb (0 = MRC = 4) - subacute (up to six months after acute event) or chronic (more than 6 months from the acute event) condition - able to sit upright for the duration of the test ( ~1h) - level of cognitive capacity to follow instructions related to the performance exercise

Exclusion criteria

Exclusion criteria: General: - high level of spasticity (MAS: in general > 3, but > 2 for motorized joints) - pain in the affected upper limb (NRS > 4) - severe psychiatric disorder - permanent neurologic 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 FES-related: - metal implants within the stimulated area - severe epilepsy or frequent epileptic seizures in the past - cancer - wounds in the application area of the electrodes or measuring equipment - no movement resulting from stimulation Robot-related: - inadequate fitting of the exoskeleton

Design outcomes

Primary

MeasureTime frame
Feasibility, functionality, and usability of the system in full as well as its modules in a single or integrated modality are the main outcome parameters of this evaluation

Secondary

MeasureTime frame
Secondary outcomes refer to specific aspects of the primary outcomes. - technical specification and reliability (feasibility) - performance, adaptability, and evaluation parameters (functionality) - acceptability, wearability, and user-friendliness (usability)

Countries

Germany, Italy

Contacts

Public ContactKlaus Jahn

Schön Klinik Bad Aibling SE & Co. KG und Deutsches Schwindel- und Gleichgewichtszentrum

KlJahn@schoen-klinik.de+49 8061 903 2500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026