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.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Based on the findings of meta-analyses, upper limb robotic rehabilitation has shown to enhance daily living activities, motor function, and strength in stroke patients. However, when compared to traditional methods, recent randomized controlled trials conducted on larger participant groups failed to identify significant differences in motor-related outcomes between the two approaches. In addition to motor deficits, stroke survivors often experience cognitive decline and sensory disturbances, which can significantly impede their recovery process. The introduction of multisensory stimulation and an enriched environment through robotic interventions may offer valuable supplementary treatments in these specific areas. Nevertheless, this aspect of treatment has not been thoroughly explored. This study seeks to assess the effectiveness of upper limb robotic rehabilitation in individuals recovering from subacute strokes, in comparison to conventional treatments. Specifically, it aims to determine whether this robotic therapy can lead to improvements in (a) cognitive deficits, (b) somatosensory impairment, and (c) how these sensory and cognitive deficits influence the process of 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
+390633086553
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2026-01
Participants
Target number of participants: 126
Treatments
Experimental: Robotic Rehabilitation
Active_comparator: Conventional treatment
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus
Collaborators: IRCCS Centro Neurolesi Bonino Pulejo, Scuola Superiore Sant'Anna di Pisa

This content was sourced from clinicaltrials.gov