Comparing robotic rehabilitation and occupational therapy for upper limb recovery after stroke
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Locations | 1 site (Florence, Italy) |
| Trial ID | NCT06884553 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with robotic rehabilitation approaches, indicating potential for success in this novel application.
Eligibility criteria
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 this trial is running
Florence, Italy
- 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
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.