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Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

NCT06649968 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-10-31

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Christian Cipriani

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649968 on ClinicalTrials.gov