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Search / Trial NCT06884553

Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

Launched by UNIVERSITY OF FLORENCE · Mar 13, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Robotic Rehabilitation Occupational Therapy Chronic Stroke Upper Limb Impairment Biomarkers Manual Dexterity

ClinConnect Summary

This clinical trial is studying the effectiveness of two different rehabilitation methods—robotic rehabilitation and traditional occupational therapy—for helping patients recover the use of their arms after a stroke. The focus is on patients who have had a stroke at least six months ago and still have difficulties moving their affected upper limb. Participants will be randomly assigned to one of three groups: one will use a robotic device called Gloreha Sinfonia, another will receive occupational therapy focused on practical tasks, and the third will follow a home exercise program. The trial aims to assess how well each method improves arm movement and overall quality of life over a treatment period of five weeks, with evaluations at the start, after treatment, and six months later.

To be eligible for this trial, participants must have experienced their first stroke at least six months ago and have ongoing difficulty moving their affected arm. They should also be willing to participate and provide consent. However, individuals with severe muscle stiffness or other specific health conditions that could interfere with the study will not be included. Throughout the trial, participants can expect to engage in various rehabilitation activities tailored to their assigned group, and the study will also look at how these treatments affect their mental well-being and recovery.

Gender

ALL

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.

About University Of Florence

The University of Florence is a leading academic institution in Italy, renowned for its commitment to advancing scientific research and education in the medical field. With a rich history of innovation and collaboration, the university actively engages in clinical trials aimed at improving healthcare outcomes. Its multidisciplinary approach integrates cutting-edge research with clinical practice, fostering an environment that encourages the development of new therapies and treatment protocols. The University of Florence is dedicated to enhancing patient care through rigorous scientific inquiry and ethical standards in clinical research.

Locations

Florence, , Italy

Patients applied

0 patients applied

Trial Officials

Francesca Cecchi, MD

Principal Investigator

University of Florence

Chiara Castagnoli, PT

Principal Investigator

Fondazione Don Carlo Gnocchi Onlus

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported