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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
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 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.
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.
Fondazione Don Carlo Gnocchi Onlus
Florence, Italy, Italy
RECRUITINGManual 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: 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).
Upper limb motor skills
Wolf Motor Function Test (Wolf et al., 2001) - Minimal Clinically Important Difference (MCID) for Functional Ability: 1.0 points (paretic dominant limb), 1.2 points (paretic non-dominant limb), 17% change (paretic dominant limb), 20% change (paretic non-dominant limb); MCID for Time: -19 seconds, 16% change (paretic dominant limb) (Lang et al., 2008); Minimal Detectable Change (MDC) for timed items: 0.7 seconds; MDC for Functional Ability Scale: 0.1 points (Fritz et al., 2009).
Time frame: 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).
Manual dexterity and activities of daily living abilities
ABILHAND questionnaire (Ekstrand et al., 2014) - Minimal Clinically Important Difference (MCID) ranges from 0.26 to 0.35 logits (Wang, 2011).
Time frame: 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).
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS) (Snaith, 2003) - Minimal Clinically Important Difference (MCID) for Anxiety = 1.96, MCID for Depression = 1.55 (in the context of Cardiovascular Diseases) (Lemay et al., 2018).
Time frame: 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).
Cognitive functioning screening
Montreal Cognitive Assessment (MOCA) (Shi et al., 2018) - Minimal Detectable Change (MDC) = 3.94 (90% CI), 4.21 (95% CI) - values for the elderly population and geriatric care (Feeney et al., 2016).
Time frame: 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).
Neglect
Hearts Test (Mancuso et al., 2016)
Time frame: 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).
Health status and quality of life
Short Form 12 (SF-12) (Gandek et al., 1998) - Minimal Clinically Important Difference (MCID) = 1.8-3.0 units (Fu et al., 2021).
Time frame: 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).
Shoulder/elbow/hand pain
Numeric Rating Scale (NRS) (Ferreira-Valente et al., 2011) ranging from 0 (no pain) to 10 (worst possible pain)
Time frame: 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).
Participation
Frenchay Activity Index (FAI) (Antonucci et al., 2022)
Time frame: 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).
Perceived change
Seven-level Likert scale (much worse, worse, somewhat worse, about the same, somewhat improved, improved, much improved) (Likert, 1932)
Time frame: 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).
Treatment satisfaction
NRS 0-10 (Van Berckel et al., 2016)
Time frame: 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).
Neuroplasticity
correlation between outcome measures and variations in surface markers of extracellular vesicles (EVs) as a complex biomarker of neuroplasticity, vascular regeneration, and inflammatory response, assessed through Surface Plasmon Resonance imaging (SPRi)
Time frame: 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).
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