Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

Launched by CHRISTIAN CIPRIANI · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the DESC-Glove, which is designed to help people recover from strokes by improving their hand movement and control. The glove provides gentle vibrations to help patients rebuild strength and coordination in their hands. Researchers want to find out how well the glove works, if it's safe to use, and whether patients and doctors find it helpful during rehabilitation. They will compare three groups of participants: one group will use the DESC-Glove with vibrations, another group will use the glove without vibrations, and the third group will receive traditional rehabilitation without the glove.

To participate in this trial, individuals must have had a stroke within the last 1 to 6 months and have mild to moderate difficulty using their affected hand. However, those with severe cognitive issues, high muscle stiffness, or who are already in another rehabilitation study will not be eligible. If someone joins the study, they can expect to use the DESC-Glove during their rehabilitation sessions and share their experiences, which will help improve the device and future stroke treatments. The trial is currently looking for participants aged 65 and older.

Gender

ALL

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.