Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Stroke
In brief
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).
Key facts
- Study ID
- NCT06649968
- Run by
- Christian Cipriani
- People needed
- 47
- Starts
- 2024-10-21
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2024-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza — Roma, Italy (enrolling)
- Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Acerenza, Italy
- Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente — Milan, Italy
- Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare — Salerno, Italy
- Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi, Italy
- Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Tricarico, Italy
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.