Evaluation of a Haptic Glove for Assessing Tactile Perception in Post-Stroke Patients

NCT06643273 | Recruiting

• 2 other identifiers: SCORES-haptic gloveGR-2021-12374896
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of the SCORES Haptic Glove Study is to assess the technical features, safety, and reliability of a sensor-equipped glove designed to evaluate tactile perception. This will help guide further technical and functional improvements to finalize the device. The secondary goal is to validate a new tactile sensitivity index based on data collected using the glove. This will be done in a randomized controlled multicenter study (ClinicalTrials.gov ID NCT06109324) aimed to compare the effectiveness of robotic upper limb rehabilitation to conventional treatment in improving cognitive and sensory deficits, as well as evaluating the impact of these deficits on motor recovery.

Conditions

Stroke

Keywords

tactile perception; haptic glove; robotics; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number and types of the haptic glove malfunctions that occurred during the study, along with their descriptions (Feasibility evaluation)

  Number and types of the haptic glove malfunctions that occurred during the study, along with their descriptions.

  Baseline; within 2 days after the end of rehabilitation treatment; within 2 days after the end of rehabilitation treatment; 6 months after the end of treatment.

Secondary Outcomes (3)

• Number of stimulations provided by the haptic glove and correctly identified in terms of intensity and localization (test-retest reliability)

  Baseline; within two day after baseline

• Number of stimulations correctly identified in terms of intensity and localization (responsiveness)

  Baseline; within 2 days after the end of rehabilitation treatment; 6 months after the end of treatment.

• Number of stimulations correctly identified in terms of intensity and localization (clinical validity)

  Baseline; within 2 days after the end of rehabilitation treatment.

Study Arms (2)

Robotic Rehabilitation

EXPERIMENTAL

Robotic Rehabilitation of the upper limb

Other: Robotic rehabilitation

Conventional Rehabilitation

ACTIVE COMPARATOR

Conventional Rehabilitation of the upper limb

Other: Conventional rehabilitation

Interventions

Robotic rehabilitation OTHER

Upper limb rehabilitation using a set of 4 devices. A set of motor/cognitive exercises will be selected to train also attention, memory, executive function, speed of processing, and visuospatial abilities.The following devices will be used: (a) a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints (Motore, Humanware); (b) a robotic device that allows passive, active, and active-assistive finger flexion and extension movements (Amadeo, Tyromotion); (c) a sensor-based system that allows unsupported 3-dimensional movements of shoulder, elbow, and wrist joint, both unimanual and bimanual (Pablo, Tyromotion); and (d) a robotic system that allows 3-dimensional, unimanual and bimanual, movements of the shoulder joint, with arm weight support (Diego, Tyromotion). The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.

Robotic Rehabilitation

Conventional rehabilitation OTHER

Upper limb rehabilitation using conventional techniques, focused on upper limb reprogramming sensorimotor function, hypertonus, inhibition and functional improvement. The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.

Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a single event, verified by MRI or CT;
• age between 18 and 85 years;
• time since stroke within six months;
• a demographically adjusted total score of the Montreal Cognitive Assessment (MoCA) between 15.5 and 22.23

You may not qualify if:

• behavioural and cognitive disorders and/or reduced compliance that would interfere with active therapy;
• fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
• severe deficits in visual acuity.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator

Study Sites (3)

IRCCS Fondazione Don Carlo Gnocchi

Florence, Italy, 50143, Italy

RECRUITING

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, 98123, Italy

RECRUITING

Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

Roma, Italy, 00166, Italy

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

Marco Germanotta, PhD

CONTACT

3805464652; mgermanotta@dongnocchi.it

Chiara Fanciullacci, PhD

CONTACT

ctu@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)