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
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
Treatments tested in this trial
- Robotic rehabilitation
- Conventional rehabilitation
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
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