Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

Last updated: March 13, 2025
Sponsor: University of Florence
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Control

Occupational therapy

Robotic therapy (Gloreha Sinfonia system)

Clinical Study ID

NCT06884553
REDIRECT
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  1. Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal toor greater than 3).

  2. Orthopedic, rheumatological, and/or peripheral nervous system disorders affectingthe paretic upper limb.

  3. Neurodegenerative and neuromuscular disorders.

  4. Acute pathologies affecting other body systems.

  5. Severe cognitive, language, and behavioral disorders that significantly limitunderstanding and participation in the planned activities.

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: Control
Phase:
Study Start date:
September 19, 2023
Estimated Completion Date:
September 19, 2025

Connect with a study center

  • Fondazione Don Carlo Gnocchi Onlus

    Florence, 50100
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.