Stroke Clinical Trials

Find Stroke Clinical Trials Near You

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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
NOT_YET_RECRUITING
Acerenza
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
NOT_YET_RECRUITING
Milan
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
RECRUITING
Roma
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
NOT_YET_RECRUITING
Salerno
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
NOT_YET_RECRUITING
Sant'angelo Dei Lombardi
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
NOT_YET_RECRUITING
Tricarico
Contact Information
Primary
Christian Cipriani, PhD
christian.cipriani@santannapisa.it
+39 050 883133
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-07
Participants
Target number of participants: 47
Treatments
Experimental: Experimental Group
Hand rehabilitation using the device
Sham_comparator: Sham Group
Hand rehabilitation while wearing the device, without providing vibrations to the patients.
Active_comparator: Control Group
Hand rehabilitation without using the device
Related Therapeutic Areas
Sponsors
Leads: Christian Cipriani

This content was sourced from clinicaltrials.gov