Evaluation of a Haptic Glove for Assessing Tactile Perception in Post-Stroke Patients
A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke. The SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) Study. Evaluation of a Haptic Glove.
Fondazione Don Carlo Gnocchi Onlus
126 participants
Oct 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
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.
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.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06643273