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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic rehabilitation

    Other intervention

    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

    Other intervention

    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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Robotic RehabilitationExperimental treatment 1 intervention
Group B: Conventional RehabilitationActive comparator 1 intervention

Trial outcomes

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.

Time frame
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

1

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

The number of stimulations provided by the haptic glove and correctly identified by the patient in terms of intensity and localization at baseline and within two days after baseline will be assessed to evaluate the measure's test-retest reliability

Time frame
Baseline; within two day after baseline
2

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

The number of stimulations provided by the haptic glove and correctly identified by the patient in terms of intensity and localization before and after the intervention will be assessed to evaluate the measure's responsiveness

Time frame
Baseline; within 2 days after the end of rehabilitation treatment; 6 months after the end of treatment.
3

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

The number of stimulations provided by the haptic glove and correctly identified by the patient in terms of intensity and localization before and after the intervention will be correlated with the Semmes-Weinstein monofilament test at the same timepoint to assess measure's clinical validity

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator

IRCCS Centro Neurolesi Bonino Pulejo

Collaborator

Source ClinicalTrials.gov
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