Robotic exercises for improving sensory and cognitive outcomes in 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.
This study tests if robotic exercises can help stroke patients recover better in their thinking and feeling abilities compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 3 sites (Florence and 2 other locations) |
| Trial ID | NCT06109324 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of upper limb robotic rehabilitation compared to conventional rehabilitation methods in stroke patients recovering from subacute strokes. It aims to assess improvements in cognitive domains and somatosensory impairments through a randomized controlled trial involving 126 participants. Patients will be assigned to either robotic or conventional treatment groups, with both groups receiving daily therapy sessions for six weeks. The study seeks to explore the potential benefits of robotic interventions in enhancing recovery beyond traditional approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have experienced a single stroke event within the last six months and have a specific range of cognitive assessment scores.
Not a fit: Patients with severe cognitive disorders, fixed limb deformities, or significant visual impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive and sensory recovery for stroke patients, enhancing their overall rehabilitation outcomes.
How similar studies have performed: While robotic rehabilitation has shown promise in enhancing motor function, this specific focus on cognitive and sensory outcomes in stroke recovery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Florence and 2 other locations
- IRCCS Fondazione Don Carlo Gnocchi — Florence, Italy (Recruiting)
- IRCCS Centro Neurolesi Bonino Pulejo — Messina, Italy (Recruiting)
- Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Marco Germanotta, PhD
- Email: mgermanotta@dongnocchi.it
- Phone: +390633086553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.