Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

Official title

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

Overview

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).

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.

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,
• 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,
• 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.

Primary outcome measures

• Device malfunctioning: number and types of device malfunctions [Time frame: For both the first and second phase of the study: within one day after each rehabilitation session.]
• Device malfunctioning: number of dropouts device-related [Time frame: For both the first and second phase of the study: within one day after each rehabilitation session.]

Secondary outcome measures (9)

• Clinical outcome: Box and Blocks test [Time frame: 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: Frenchay Arm Test [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).]
• Questionnaire: Technology Acceptance Model [Time frame: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 6 centers

• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Acerenza
• Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente — Milan
• Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza — Roma
• Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare — Salerno
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Tricarico

Identifiers

NCT: NCT06649968 · DESC-Glove Validation · PNC0000007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗