NCT06890481Not yet recruiting
Robotic rEhabilitation sCenario fOr patieNts With NeglECT
Collaborative Development of a Virtual Reality Scenario, Integrated Into a Robotic Upper Limb Rehabilitation Device, for the Treatment of Unilateral Spatial Negligence (NSU) Through Mutisensory Stimulation: Feasibility and Usability Pilot Study
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 the MOTORE device. This study will focus on the rehabilitation of the upper limbs in post-stroke patients with plegia and left-sided hemi-inattention. The main questions it aims to answer are: * The evaluation of the usability and acceptability of the newly developed scenario * The evaluation of the effects of the new scenario on patients' hemi-inattention * The evaluation of changes in upper limb functional parameters Participants will undergo a total of 13 rehabilitation sessions, each lasting 45 minutes, using the new scenario, including an initial and final assessment.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT06890481
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 1 Apr 2025 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of cognitive decline prior to the event
- Presence of previous stroke events
Other illness
- Orthopaedic, neurological, or psychiatric disorders that could interfere with the study procedures and motor or cognitive assessments
Other
- 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
- Unstable fractures of the upper limb
- Severe osteoporosis
- Skin lesions on the upper limb
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi onlus Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.