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

NCT ID: NCT06643273

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-04-30

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.

Detailed Description

Sensory and proprioceptive deficits in the upper limbs affect about 50-85% of stroke survivors. These deficits can impact single sensations (such as primary tactile senses like light touch, pressure, and localization) and the ability to discriminate between different materials or temperatures, as well as proprioception and multiple somatosensory modalities. Furthermore, somatosensory deficits have been strongly correlated with variations in treatment responses among patients. However, in clinical practice, the use of appropriate quantitative tools to measure these deficits is not widespread, and evidence for active sensory training remains limited.

In recent years, robotic therapy has been proposed as an effective approach for upper limb rehabilitation. Nevertheless, recent studies with large samples have failed to demonstrate the superiority of robotic treatment over traditional methods regarding the recovery of upper limb motor functions. These studies primarily focus on motor aspects of stroke recovery, often neglecting sensory and cognitive aspects of rehabilitation, whether robotic or conventional.

Actually, there is limited evidence supporting the superiority of robotic approaches over conventional rehabilitation in recovering cognitive deficits and sensitivity. Additionally, it remains unclear whether cognitive and/or sensory deficits impact motor outcomes differently when using robotic versus conventional approaches.

To address this, the SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) study is a multicenter randomized controlled study investigating the effects of robotic rehabilitation on cognitive and sensory deficits in stroke survivors. It aims to compare robotic and conventional rehabilitation approaches regarding cognitive recovery and tactile sensitivity in subacute stroke patients. While some quantitative methods exist to assess absolute perception levels of tactile stimuli, standardized, repeatable, and objectively quantitative methods for assessing localization ability are lacking. Therefore, this study will evaluate how the tactile perceptual abilities of recruited patients evolve during and after a rehabilitation course-whether robotic or conventional-using a specifically developed haptic device that includes a glove with integrated vibrotactile elements. This system aims to objectively define patients' tactile sensitivity through psychophysical evaluations involving the identification and localization of randomized vibrations delivered to the surface of the hand affected by sensorimotor alterations. Specifically, this study will investigate the test-retest reliability, discriminant ability, responsiveness, and clinical validity of the metrics obtained from the haptic glove.

During each experimental session, randomized vibrotactile stimuli will be administered to the recruited patient at different sites on the hand. The patient will be asked to identify and verbally communicate the site of each perceived vibration, as well as the intensity of the vibration itself between the two possible levels.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robotic Rehabilitation

Robotic Rehabilitation of the upper limb

Group Type: EXPERIMENTAL

Robotic rehabilitation

Intervention Type: 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.

Conventional Rehabilitation

Conventional Rehabilitation of the upper limb

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: 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.

Interventions

Robotic rehabilitation

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.

Intervention Type: OTHER

Conventional rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Florence, , Italy

IRCCS Centro Neurolesi Bonino Pulejo

Messina, , Italy

Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

Roma, , Italy

Countries

Italy

Central Contacts

Marco Germanotta, PhD

Role: CONTACT

mgermanotta@dongnocchi.it

3805464652

Chiara Fanciullacci, PhD

Role: CONTACT

ctu@dongnocchi.it

Other Identifiers

GR-2021-12374896

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SCORES-haptic glove

Identifier Type: -

Identifier Source: org_study_id