Clinical trial NCT06884553: Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: Robotic rehabilitation
occupational therapy
chronic stroke
upper limb impairment
biomarkers
manual dexterity
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2025-03-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, prospective, randomized controlled trial (RCT) designed for nonprofit purposes and aimed at demonstrating superiority.
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Manual dexterity
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Secondary outcomes:
measure: Upper limb motor skills
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Manual dexterity and activities of daily living abilities
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Anxiety and depression
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Cognitive functioning screening
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Neglect
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Health status and quality of life
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Shoulder/elbow/hand pain
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Participation
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Perceived change
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Treatment satisfaction
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
measure: Neuroplasticity
timeFrame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
Study officials:
affiliation: University of Florence
name: Francesca Cecchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Chiara Castagnoli, PT
role: PRINCIPAL_INVESTIGATOR
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