Comparing robotic rehabilitation and occupational therapy for upper limb recovery after stroke
Official title: Effects of Robot-assistED Rehabilitation Versus OccupatIonal Therapy on the Functional Recovery of the Upper Limb in PatiEnts with Chronic STroke: a Randomized Controlled Trial
Run by University of Florence · NCT06884553 · Data updated 2026-11-12
This study is testing whether robotic therapy or regular occupational therapy helps stroke survivors improve the use of their affected arm and hand.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | University of Florence Academic / other |
| Locations | 1 site (Florence, Italy) |
| Status | Recruiting |
| Started | September 19, 2023 |
| Main results expected | September 19, 2025 |
| Study ends | September 19, 2025 |
| Registry record updated | March 19, 2025 |
| Trial ID | NCT06884553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have had their first stroke at least six months ago and have persistent motor deficits in the affected upper limb.
✕Probably not a fit
Patients with severe spastic hypertonia or other significant neurological or orthopedic disorders affecting the upper limb may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of robotic rehabilitation using the Gloreha Sinfonia system versus traditional occupational therapy for improving upper limb function in patients who have experienced a stroke at least six months prior. Participants with persistent motor deficits will be randomly assigned to either the robotic therapy group or the occupational therapy group, focusing on enhancing manual dexterity and cognitive stimulation through serious games. The primary outcome measured will be the improvement in functional recovery of the affected upper limb.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies that enhance upper limb recovery and quality of life for stroke survivors.
How similar studies have gone: Other studies have shown promising results with robotic rehabilitation approaches, indicating potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Fondazione Don Carlo Gnocchi Onlus
Florence, Italy, Italy Recruiting
Study contacts
- Principal investigator: Francesca Cecchi, MD — University of Florence
- Study coordinator: Francesca Cecchi, MD
- Email: francesca.cecchi@unifi.it
- Phone: 3388627184
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Task-oriented training plus NDT vs high-intensity gait training plus NDT for chronic stroke walking
In adults with chronic stroke, the study tests whether adding structured, high-repetition task-oriented training or high-intensity gait training to neurodevelopmental treatment improves walking ability more than NDT alone.
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Action Observation Therapy for Chronic Stroke via Telerehabilitation
This study tests whether watching and then imitating simple daily actions through a home-based telerehabilitation program improves hand function and quality of life for adults with chronic stroke.
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Unimanual vs. Bimanual Action Observation Therapy for Chronic Stroke Upper-Limb Recovery
This study tests whether action observation therapy using one hand or both hands improves arm function and daily living in adults with chronic stroke.
-
CONUT score and its link to balance and everyday function after chronic stroke.
This will see if the CONUT nutritional score and measures of muscle and bone relate to balance and daily function in adults at least six months after a stroke.
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Comparing constraint-induced movement therapy and bilateral training to improve arm and hand use after chronic stroke
This tests whether restraining the unaffected arm plus electrical stimulation or training both arms together with electrical stimulation better reduces wrist tightness and improves hand use in adults with chronic stroke.
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Using vibration and low‑intensity electrical pulses to improve arm proprioception after stroke
This project tests whether a wearable device that delivers gentle vibrations and low‑intensity electrical pulses can improve arm position and movement sense in people with chronic stroke, with healthy volunteers included for comparison.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.