Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

ConditionChronic Stroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Florence

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

First ischemic or hemorrhagic stroke occurring at least 6 months prior.

Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77).

Willingness to participate in the study, with the provision of informed consent.

Disqualifiers

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

Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb.

Neurodegenerative and neuromuscular disorders.

Acute pathologies affecting other body systems.

Trial design

Design model

Parallel

Treatments tested in this trial

Robotic therapy (Gloreha Sinfonia system)
Device
Group A will receive rehabilitative treatment using the Gloreha Sinfonia system . The treatment regimen spans five weeks and encompasses a progressive series of exercises. Gloreha features an adaptable mechanical design developed for hand rehabilitation. Its activities involve grasping and releasing, facilitated through a lightweight and flexible orthosis. The device, comprising a robotic glove and mechanical arm, enables both finger mobility and upper limb support, facilitating semi-autonomous execution of motor tasks. Gloreha's versatility allows for exercises involving the entire upper limb, including motor-cognitive "serious games" utilizing virtual reality and interaction with real objects. Real-time feedback enhances patient self-assessment. Moreover, the robot incorporates an automated component interfacing with flexion sensors, gauging the patient's autonomous engagement in Occupational Therapy tasks and serious games.
Occupational therapy
Other intervention
Occupational Therapy is also recommended in Stroke Rehabilitation Clinical Guidelines. However, its implementation in rehabilitation services in Italy is still limited, presumably due to regulatory factors. For stroke patients, the goal of occupational therapy is to enhance the ability to perform activities of daily living, often focusing on the use of the hand and upper limb in purposeful tasks. Strategies employed by occupational therapists include assessment, treatment, compensation strategies, assistive technologies, and environmental adaptations. Occupational therapy appears to enhance performance in activities of daily living and reduce the likelihood of impairment in these abilities, although the evidence is of low quality. There is also limited and moderately quality evidence in the area of occupational therapy for addressing depressive and anxiety symptoms in hospital-based rehabilitation for physical disabilities.
Control
Behavioral
Participants will be provided guidance by a skilled physiotherapist to follow a customized exercise regimen independently within the comfort of their homes. This program will specifically target the upper limb and will be tailored according to the evaluation performed at the initial assessment.

Treatment groups

72 Participants

are divided into 3 treatment groups

Group A: Group A - Robotic therapyExperimental treatment 1 intervention

Group B: Group B - Occupational TherapyExperimental treatment 1 intervention

Group C: Group C - Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Manual dexterity

Nine Hole Peg Test (Johansson et al., 2019) - MCID=32s (Sivan et al., 2011); MDC =32,8 sec; Percentage Change=54% (Chen et al., 2009)

Time frame