NCT06109324 Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)
| NCT ID | NCT06109324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2023-11-13 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Marco Germanotta, PhD
STUDY DIRECTOR
IRCCS Fondazione Don Carlo Gnocchi
Frequently Asked Questions
Who can join the NCT06109324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06109324 currently recruiting?
Yes, NCT06109324 is actively recruiting participants. Contact the research team at mgermanotta@dongnocchi.it for enrollment information.
Where is the NCT06109324 trial being conducted?
This trial is being conducted at Florence, Italy, Messina, Italy, Roma, Italy.
Who is sponsoring the NCT06109324 clinical trial?
NCT06109324 is sponsored by Fondazione Don Carlo Gnocchi ETS. The principal investigator is Marco Germanotta, PhD at IRCCS Fondazione Don Carlo Gnocchi. The trial plans to enroll 126 participants.
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