NCT06884553 Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation
| NCT ID | NCT06884553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florence |
| Condition | Chronic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2025-09-19 |
Eligibility & Interventions
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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 72 participants in total. It began in 2023-09-19 with a primary completion date of 2025-09-19.
⚠ 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
The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.
Eligibility Criteria
Inclusion Criteria: 1. First ischemic or hemorrhagic stroke occurring at least 6 months prior. 2. Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77). 3. Willingness to participate in the study, with the provision of informed consent. Exclusion Criteria: 1. Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal to or greater than 3). 2. Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb. 3. Neurodegenerative and neuromuscular disorders. 4. Acute pathologies affecting other body systems. 5. Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.
Contact & Investigator
Francesca Cecchi, MD
PRINCIPAL INVESTIGATOR
University of Florence
Frequently Asked Questions
Who can join the NCT06884553 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06884553 currently recruiting?
Yes, NCT06884553 is actively recruiting participants. Contact the research team at francesca.cecchi@unifi.it for enrollment information.
Where is the NCT06884553 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT06884553 clinical trial?
NCT06884553 is sponsored by University of Florence. The principal investigator is Francesca Cecchi, MD at University of Florence. The trial plans to enroll 72 participants.
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