NCT06649968 Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
| NCT ID | NCT06649968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christian Cipriani |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 47 participants in total. It began in 2024-10-21 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the DESC-Glove, an instrumented glove developed for sensorimotor rehabilitation in individuals recovering from a stroke, utilizing non-invasive vibrational feedback. The primary objective is to assess the technical functionality, safety, and reliability of the device during post-stroke rehabilitation, providing insights for future technical and functional improvements. The secondary objectives are: 1. To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals; 2. To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals. To meet the second objective, researchers will compare three groups: an experimental treatment group (using the DESC-Glove during hand rehabilitation), a sham control group (using the DESC-Glove without vibration), and a conventional control group (receiving hand rehabilitation without the device).
Eligibility Criteria
Inclusion Criteria: * Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI); * Time from the acute event between 1 and 6 months; * Mild to moderate impairment of the upper limb, assessed using the Motricity Index (item score for "pinch grip" ≥ 19 and scores for "elbow flexion" and "shoulder abduction" ≥ 14). Exclusion Criteria: * Severe behavioral and cognitive disorders (Montreal Cognitive Assessment (MoCA) ≤ 15 ) and/or decreased compliance; * Spasticity or hypertonia (Modified Ashworth Scale (MAS) \> 3) in the affected limb; * Concurrent participation in a rehabilitation trial that includes treatment training for the upper limb following a stroke; * Refusal to sign informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06649968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649968 currently recruiting?
Yes, NCT06649968 is actively recruiting participants. Contact the research team at christian.cipriani@santannapisa.it for enrollment information.
Where is the NCT06649968 trial being conducted?
This trial is being conducted at Acerenza, Italy, Milan, Italy, Roma, Italy, Salerno, Italy and 2 additional locations.
Who is sponsoring the NCT06649968 clinical trial?
NCT06649968 is sponsored by Christian Cipriani. The trial plans to enroll 47 participants.
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