Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06649968
NA

Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

Sponsor: Christian Cipriani

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.

OTHER

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