Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: DESC-Glove (active); Device: DESC-Glove (sham); Other: Traditional rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 47
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Cipriani, PhD; Phone Number: +39 050 883133; Email: christian.cipriani@santannapisa.it

Study Locations

• Italy
  • Acerenza, Italy
    • Not yet recruiting
    • Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
    • Contact: Rocco Santarsiero
  • Milano, Italy
    • Not yet recruiting
    • Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
    • Contact: Claudia Salatino
  • Roma, Italy
    • Recruiting
    • Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
    • Contact: Irene G Aprile, PhD; Phone Number: +390633086500; Email: iaprile@dongnocchi.it
  • Salerno, Italy
    • Not yet recruiting
    • Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
    • Contact: Maria R Leone
  • Sant'Angelo Dei Lombardi, Italy
    • Not yet recruiting
    • Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
    • Contact: Tommaso Cibellis
  • Tricarico, Italy
    • Not yet recruiting
    • Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
    • Contact: Massimo Tolve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Hand rehabilitation using the device	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.
Sham Comparator: Sham Group; Hand rehabilitation while wearing the device, without providing vibrations to the patients.	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.
Active Comparator: Control Group; Hand rehabilitation without using the device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device malfunctioning: number and types of device malfunctions	This outcome measure is designed to systematically document and analyze any malfunctions of the DESC-Glove device throughout the study. All malfunctions will be recorded in detail, including the frequency and type of malfunction. Each issue will be categorized based on the nature of the malfunction, such as hardware failures (e.g., sensor or vibration issues), software, or connectivity problems. This data will be used to assess the overall reliability and functionality of the device, guiding future improvements and treatment efficacy.	For both the first and second phase of the study: within one day after each rehabilitation session.
Device malfunctioning: number of dropouts device-related	This outcome measure aims to document the number of participants who withdraw from the study specifically due to issues related to the device.	For both the first and second phase of the study: within one day after each rehabilitation session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome: Frenchay Arm Test	The Frenchay Arm Test (FAT) is an assessment tool designed to measure upper extremity proximal motor control and dexterity during activities of daily living (ADL) in patients with neurological impairments. It focuses on evaluating activity limitations specific to the upper extremities. Each of the test's five items is scored as either a pass (1) or fail (0), with total scores ranging from 0 to 5.	For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: Thumb Localizing Test	The Thumb Localizing Test is an assessment used to evaluate proprioception and sensory awareness in the hand. During the test, the examiner places the participant's thumb in various positions, either passively or with minimal resistance, while the participant's eyes are closed. The participant is then asked to replicate the position of their thumb with their opposite hand or to indicate the position of their thumb using verbal or tactile cues. It ranges from 0 (normal) to 3 (severely impaired).	For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: 5-level EQ-5D	The 5-level EQ-5D is a standardized instrument used to measure health-related quality of life. It consists of a descriptive system and a visual analogue scale (VAS). The descriptive system evaluates five dimensions of health - mobility, self-care, usual activities, pain/discomfort and anxiety/depression - each with five levels of severity. The result is calculated by assigning a numerical value to each response level and summing these values across the five items.	For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Instrumental Outcome: Pick and Lift test	The Pick and Lift Test (PLT) assesses the ability of participants to lift a sensorized object using a bi-digit grip with their thumb and index finger. During the test, participants repeatedly lift the object while the levels of force applied during the manipulation tasks are recorded. The PLT is conducted under three conditions: (a) with the DESC-Glove providing vibratory feedback, (b) with the DESC-Glove not providing vibrations, and (c) without the DESC-Glove altogether. This design allows for an evaluation of the impact of vibratory feedback on force application and manipulation skills. Such a system is not intended as a clinical validation tool but rather as a means of data acquisition to extract metrics considered standard in the scientific literature regarding motor coordination in manipulation.	For both the first and second phase of the study: Baseline (within 3 days before the first rehabilitation session); Weekly assessment (within 3 days after the last rehab session of each week).
Instrumental Outcome: Pick and Place test	The Pick and Place Test (PPT) with a fragile object involves performing a series of movements to transfer a fragile item from one side of a barrier to the other. This object walls collapse when the gripping force applied to these walls exceeds a certain threshold. It measures the participant's ability to regulate grip strength and dexterity. Such a system is not intended as a clinical validation tool but rather as a means of data acquisition to extract metrics considered standard in the scientific literature regarding motor coordination in manipulation.	For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Questionnaire: System Usability Scale	The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. A SUS score can range from 0 to 100, with higher scores indicating better usability. This questionnaire will be evaluated exclusively within the experimental group.	For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Questionnaire: Gradibility of the Device	The Gradibility Questionnaire has been specifically designed to provide a thorough assessment of user experiences. It consists of 13 items that evaluate the usability, acceptability, and satisfaction of users testing the device. This questionnaire will be evaluated exclusively within the experimental group.	For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Questionnaire: Technology Acceptance Model	The Technology Acceptance Model is designed to identify the determinants influencing the acceptance of Robotic and Allied Technology. It comprises four sections: perceived usefulness, ease of use, compatibility, and intention to use. Each question utilizes a 7-point Likert scale, ranging from 1 (worst) to 7 (best). The scoring for each section is calculated as the average of the responses, with scores ranging from 1 (worst) to 7 (best). This questionnaire will be evaluated exclusively within the experimental group.	For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: Box and Blocks test	The Box and Blocks Test is a clinical assessment used to measure manual dexterity and upper limb function. During the test, participants transfer as many small blocks as possible from one compartment of a box to another within 60 seconds. The score is based on the number of blocks successfully moved, reflecting hand coordination and fine motor skills. The test is conducted under three conditions: (a) with the DESC-Glove providing vibratory feedback, (b) with the DESC-Glove not providing vibrations, and (c) without the DESC-Glove altogether	For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).

Collaborators and Investigators

• Sponsor: Christian Cipriani

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: DESC-Glove Validation; PNC0000007 (Other Grant/Funding Number: Ministry of University and Research of Italy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No