Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Chronic Stroke trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment72 (estimated)
SponsorUniversity of Florence
Academic / other
Locations1 site (Florence, Italy)
StatusRecruiting
StartedSeptember 19, 2023
Main results expectedSeptember 19, 2025
Study endsSeptember 19, 2025
Registry record updatedMarch 19, 2025
Trial IDNCT06884553 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

  • Fondazione Don Carlo Gnocchi Onlus
    Florence, Italy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.