Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation (REDIRECT)

University of Florence (UNIFI)

Status: Enrolling

Conditions: Chronic Stroke

Treatments: Behavioral: Control; Other: Occupational therapy; Device: Robotic therapy (Gloreha Sinfonia system)

Study type: Interventional

Funder types: Other

Identifiers

NCT06884553

REDIRECT

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Group A - Robotic therapy

Experimental group

Description:

Group A will undergo rehabilitative treatment using Gloreha Sinfonia hand robot, administered by a physical therapist experienced in robotic rehabilitation. The treatment will involve a set of progressively challenging exercises over the course of five weeks (3 sessions per week, each lasting 1 hour). The delivery of the treatment will be conducted in a face-to-face mode.

Treatment:

Device: Robotic therapy (Gloreha Sinfonia system)

Group B - Occupational Therapy

Experimental group

Description:

Group B will attend small group occupational therapy treatment (occupational therapist/patient ratio: 1:4). Subjects will attend a rehabilitative intervention lasting a total of 5 weeks, with three sessions per week, each lasting one hour, for a total of 15 hours of treatment.

Treatment:

Other: Occupational therapy

Group C - Control Group

Active Comparator group

Description:

Group C (control group) will receive advice from an experienced physiotherapist for a personalized exercise program to be independently carried out at their own residence. The program will focus on the upper limb and will be based on the assessment conducted at baseline.

Treatment:

Behavioral: Control