Status:
NOT_YET_RECRUITING
Robotic rEhabilitation sCenario fOr patieNts With NeglECT
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Humanware S.r.l.
Conditions:
Stroke
Ischemic Stroke
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
The goal of this pilot clinical trial is to develop an integrated motor and cognitive rehabilitation program and evaluate the usability and acceptability of a new virtual reality scenario designed for...
Detailed Description
Stroke in the right hemisphere can provoke both motor and cognitive symptoms. Hemi-inattention is a cognitive deficit typical of right hemispheric damage, with an incidence ranging from 12% to 95%. Th...
Eligibility Criteria
Inclusion
- Presence of a diagnosis of right hemispheric stroke
- Presence of a diagnosis of hemi-inattention (Apple test)
- Presence of left hemiplegia (Fugl-Meyer Assessment Upper Limb ≤58)
- Adjusted Montreal Cognitive Assessment \<20
- Written informed consent
Exclusion
- Presence of cognitive decline prior to the event
- Presence of previous stroke events
- Presence of osteoarticular rigidity (e.g., ankylosis, functional limitations with traumatic or degenerative origin) or spasticity in the affected upper limb (Modified Ashworth Scale ≥3 on shoulder, elbow, or wrist)
- Inability to maintain a sitting position
- Presence of severe visual disabilities
- Recent injection of botulinum toxin in the upper limb or planned injection of botulinum toxin during the study period
- Orthopaedic, neurological, or psychiatric disorders that could interfere with the study procedures and motor or cognitive assessments
- Unstable fractures of the upper limb
- Severe osteoporosis
- Skin lesions on the upper limb
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06890481
Start Date
April 1 2025
End Date
April 1 2026
Last Update
April 3 2025
Active Locations (1)
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1
IRCCS Fondazione Don Carlo Gnocchi onlus
Florence, Firenze, Italy, 50143