Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

NCT06649968 | Recruiting

• 2 other identifiers: DESC-Glove ValidationPNC0000007
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 6

Brief 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. 1.To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
2. 2.To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Clinical outcome: Box and Blocks test

  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

  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

  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

  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

  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).

Study Arms (3)

Experimental Group

EXPERIMENTAL

Hand rehabilitation using the device

Device: DESC-Glove (active)

Sham Group

SHAM COMPARATOR

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

Device: DESC-Glove (sham)

Control Group

ACTIVE COMPARATOR

Hand rehabilitation without using the device

Other: Traditional rehabilitation

Interventions

DESC-Glove (active) DEVICE

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.

Experimental Group

DESC-Glove (sham) DEVICE

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.

Sham Group

Traditional rehabilitation OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Cipriani: lead

Study Sites (6)

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Acerenza, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente

Milan, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, Italy

RECRUITING

Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare

Salerno, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Tricarico, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Christian Cipriani, PhD

CONTACT

+39 050 883133; christian.cipriani@santannapisa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)