Evaluating a glove for rehabilitation after stroke

Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)

This study is testing a special glove to see if it helps stroke survivors improve their hand movement and recovery better than regular rehab methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Scuola Superiore Sant'Anna di Pisa (Academic / other)
• Locations: 6 sites (Acerenza and 5 other locations)
• Trial ID: NCT06649968 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the DESC-Glove, an instrumented glove designed for sensorimotor rehabilitation in stroke survivors. The study consists of two phases: the first phase involves preliminary testing of the glove's functionality on a small group of patients, while the second phase is a multicenter randomized controlled trial comparing the DESC-Glove with a sham device and traditional rehabilitation methods. The trial will evaluate the device's safety, usability, and its effects on sensorimotor performance and manual dexterity. Participants will engage in rehabilitation exercises while wearing the glove, which provides vibrational feedback to enhance recovery.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with ischemic or hemorrhagic stroke, experiencing mild to moderate upper limb impairment, and within 1 to 6 months post-stroke.

Not a fit: Patients with severe cognitive disorders, high spasticity, or those currently involved in other upper limb rehabilitation trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved rehabilitation outcomes for stroke patients, enhancing their recovery of motor skills.

How similar studies have performed: Other studies have shown promise in using technology-assisted rehabilitation approaches, suggesting potential success for this novel intervention.

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.

Where this trial is running

Acerenza and 5 other locations

• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Acerenza, Italy (Not_yet_recruiting)
• Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente — Milan, Italy (Not_yet_recruiting)
• Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza — Roma, Italy (Recruiting)
• Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare — Salerno, Italy (Not_yet_recruiting)
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi, Italy (Not_yet_recruiting)
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Tricarico, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Christian Cipriani, PhD

Conditions Stroke