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

Not Applicable

• Conditions: Paresis of the upper extremity due to ischemic or hemorrhagic stroke; I61; I63; I64; Intracerebral haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00033115
• Lead Sponsor: Schön Klinik Bad Aibling SE & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study Completion: 2024-05-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary outcomes refer to specific aspects of the primary outcomes. <br>- technical specification and reliability (feasibility)<br>- performance, adaptability, and evaluation parameters (functionality)<br>- acceptability, wearability, and user-friendliness (usability)