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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.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Fondazione Don Carlo Gnocchi
RECRUITING
Florence
IRCCS Centro Neurolesi Bonino Pulejo
RECRUITING
Messina
Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza
RECRUITING
Roma
Contact Information
Primary
Marco Germanotta, PhD
mgermanotta@dongnocchi.it
3805464652
Backup
Chiara Fanciullacci, PhD
ctu@dongnocchi.it
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2027-04
Participants
Target number of participants: 126
Treatments
Experimental: Robotic Rehabilitation
Robotic Rehabilitation of the upper limb
Active_comparator: Conventional Rehabilitation
Conventional Rehabilitation of the upper limb
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus
Collaborators: IRCCS Centro Neurolesi Bonino Pulejo, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

This content was sourced from clinicaltrials.gov