Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

Christian Cipriani

Status: Enrolling

Conditions: Stroke

Treatments: Other: Traditional rehabilitation; Device: DESC-Glove (active); Device: DESC-Glove (sham)

Study type: Interventional

Funder types: Other

Identifiers

NCT06649968

PNC0000007 (Other Grant/Funding Number)

DESC-Glove Validation

Details and patient eligibility

About

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).

Full description

The study is divided into two phases:

Phase 1: Preliminary Investigation of Device Functionality. This phase involves testing the DESC-Glove on 5 patients to assess its initial functionality. Each patient will complete four treatment sessions using the device, focusing on both fine motor exercises for the hand and gross motor exercises for the upper limb. This phase will also help evaluate patient compliance with the rehabilitation treatment on a smaller scale, allowing for a better understanding of the recovery process's duration. During the treatment, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli synchronized with the exercises, following the device's operational guidelines.

Phase 2: Multicenter Randomized Controlled Trial (RCT).

In this phase, 42 participants will be recruited and randomly assigned to one of three parallel groups (1:1:1):

The experimental treatment group (using the DESC-Glove), The sham control group (using the DESC-Glove without vibration), and The conventional control group (not using the DESC-Glove). The sample size of 42 (14 participants per group) was chosen following Julious et al. [doi: 10.1002/pst.185], which recommends a minimum of 12 subjects per group for pilot studies. This number was increased to 42 to account for potential dropouts, ensuring robust data collection and analysis.

Enrollment: 47 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 3 patient groups

Experimental Group

Experimental group

Description:

Hand rehabilitation using the device

Treatment:

Device: DESC-Glove (active)

Sham Group

Sham Comparator group

Description:

Hand rehabilitation while wearing the device, without providing vibrations to the patients.

Treatment:

Device: DESC-Glove (sham)

Control Group

Active Comparator group

Description:

Hand rehabilitation without using the device

Treatment:

Other: Traditional rehabilitation