Actively Recruiting
Assessment of the Functional Impact of a Close-loop Controlled Prehension Neuroprosthesis in Post-stroke Patients
Led by University Hospital, Toulouse · Updated on 2024-10-23
30
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the PREHENS-STROKE study is to propose a functional replacement device to restore grip capacities in patients with hemiparesis after stroke, unable to actively open the hand to seize objects. The main objective is to evaluate the impact of the use of a self-controlled prehension neuroprosthesis on the ability to perform a standardized grasping task, consisting of grasping, relocating and releasing a glass (palmar grasp) or a spoon (key-pinch), compared to a condition without the use of the prehension neuroprosthesis.
CONDITIONS
Official Title
Assessment of the Functional Impact of a Close-loop Controlled Prehension Neuroprosthesis in Post-stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Paresis of one upper limb from a single ischemic or hemorrhagic stroke confirmed by brain imaging
- Stroke occurred more than one month ago
- Unable to actively open fingers 2 to 5 to intentionally grasp an empty glass with a palmar grip
- Able to hold the glass passively placed in the hand
- Unable to voluntarily grasp the handle of a tablespoon with a key-grip
- Able to hold the spoon passively placed between thumb and index
- Able to sit on a chair for at least 1 hour and 30 minutes
- Free, informed, and written consent given by participant and investigator
- Affiliated with the French health insurance system
- At least 18 years old
- Both women and men included
- Available for 5 days of follow-up as part of routine hospitalization
You will not qualify if you...
- Pregnant or breastfeeding
- Musculotendinous retractions or joint stiffness preventing passive hand opening needed for tasks
- Limitation preventing gripping tasks while sitting
- Upper limb pain limiting performance of the standardized grasping task
- Major sensory disorders with a somesthesia score less than 10/44
- Severe aphasia reducing verbal fluency or understanding
- Unilateral spatial neglect with significant omissions
- Extensor muscles not stimulable by the neuroprosthesis
- Presence of a pacemaker
- Unstable epilepsy or cardiovascular disease
- Dermatological problems preventing electrode application
- Botulinum toxin injection in the upper limb within 30 days prior or during inclusion
- Participation in another research protocol with ongoing exclusion period
- Under legal protection or guardianship
- Refusal to sign consent
- Unable to understand information or comply due to physical or psychological health issues
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital
Toulouse, France, 31500
Actively Recruiting
Research Team
D
David GASQ, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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