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Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Sponsor: Christian Cipriani
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).
Official title: Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2024-10-21
Completion Date
2026-07
Last Updated
2024-10-31
Healthy Volunteers
No
Conditions
Interventions
DESC-Glove (active)
Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli that are synchronized with the exercises being performed.
DESC-Glove (sham)
Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, but will not receive any vibratory stimuli.
Traditional rehabilitation
Traditional rehabilitation treatment for the upper limb. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20- minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. The DESC- Glove will not be used during this treatment.
Locations (6)
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 della Provvidenza
Roma, 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