Haptic glove to measure touch perception after stroke
A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke. The SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) Study. Evaluation of a Haptic Glove.
NA · Fondazione Don Carlo Gnocchi Onlus · NCT06643273
This study will test a sensor-equipped haptic glove to see if it can reliably measure touch and tactile sensitivity in people recovering from a stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 3 sites (Florence, Italy and 2 other locations) |
| Trial ID | NCT06643273 on ClinicalTrials.gov |
What this trial studies
This multicenter study enrolls adults within six months of a single stroke to examine the technical performance, safety, and reliability of a sensor-equipped glove designed to measure tactile perception. Investigators will collect glove-derived data alongside standard clinical sensory and cognitive tests and use these data to validate a new tactile sensitivity index. The work is connected to a larger randomized trial comparing robotic and conventional upper limb rehabilitation to explore how sensory and cognitive deficits relate to motor outcomes. Study findings will guide technical refinements and support finalization of the device for clinical use.
Who should consider this trial
Good fit: Adults aged 18–85 with a single MRI- or CT-confirmed stroke within six months and a demographically adjusted MoCA score between 15.5 and 22.23 who can participate in active therapy are the intended participants.
Not a fit: Patients with severe behavioral or cognitive issues that prevent active therapy, fixed contractures of the affected limb (e.g., ankylosis or Modified Ashworth Scale = 4), severe visual deficits, or those outside the specified age/time windows are unlikely to benefit from this device-focused study.
Why it matters
Potential benefit: If successful, the glove could provide clinicians a precise, repeatable way to measure somatosensory deficits and help tailor rehabilitation to improve motor recovery.
How similar studies have performed: While robotic rehabilitation has been extensively studied and has not consistently outperformed conventional therapy for motor recovery, formal validation of wearable haptic devices for tactile sensing in stroke patients is limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a single event, verified by MRI or CT; * age between 18 and 85 years; * time since stroke within six months; * a demographically adjusted total score of the Montreal Cognitive Assessment (MoCA) between 15.5 and 22.23 Exclusion Criteria: * behavioural and cognitive disorders and/or reduced compliance that would interfere with active therapy; * fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4); * severe deficits in visual acuity.
Where this trial is running
Florence, Italy and 2 other locations
- IRCCS Fondazione Don Carlo Gnocchi — Florence, Italy, Italy (RECRUITING)
- IRCCS Centro Neurolesi Bonino Pulejo — Messina, Italy, Italy (RECRUITING)
- Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza — Roma, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Marco Germanotta, PhD
- Email: mgermanotta@dongnocchi.it
- Phone: 3805464652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, tactile perception, haptic glove, robotics, rehabilitation