Robotic rEhabilitation sCenario fOr patieNts With NeglECT (NCT06890481) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Robotic rEhabilitation sCenario fOr patieNts With NeglECT
Italy12 participantsStarted 2025-04-01
Plain-language 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 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.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Usability of the device
Timeframe: Evaluated at session 12 (after the treatment) at an average of 2 weeks
2
Acceptability of the device for the operator
Timeframe: Evaluated at session 12 (after the treatment) at an average of 2 weeks