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| Name | Class |
|---|---|
| Fondazione Don Carlo Gnocchi ETS | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Robotic therapy | Experimental | 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. |
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| Group B - Occupational Therapy | Experimental | 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. |
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| Group C - Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Description | Time Frame |
|---|---|---|
| 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). |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Cecchi, MD | Contact | 3388627184 | francesca.cecchi@unifi.it | |
| Chiara Castagnoli, PT | Contact | 3333738921 | ccastagnoli@dongnocchi.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesca Cecchi, MD | University of Florence | Principal Investigator |
| Chiara Castagnoli, PT | Fondazione Don Carlo Gnocchi ETS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Don Carlo Gnocchi Onlus | Recruiting | Florence | Italy | 50100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35179673 | Background | Antonucci L, Barbato C, Pellicciari L, Paperini A, Hochleitner I, Castagnoli C, Verdesca S, Lucidi G, Marignani S, Pancani S, Basagni B, Macchi C, Cecchi F. Italian translation and cross-cultural validation of an assessment tool for participation in stroke survivors: the Frenchay Activities Index. Neurol Sci. 2022 Jul;43(7):4297-4306. doi: 10.1007/s10072-022-05949-5. Epub 2022 Feb 18. | |
| 31834217 |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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This is a multicenter, prospective, randomized controlled trial (RCT) designed for nonprofit purposes and aimed at demonstrating superiority.
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The assessors conducting outcome evaluations and the operators performing statistical analysis will be blinded to the assignment group. Given the nature of the intervention, it will not be possible to maintain blinding regarding the treatment for both the therapists and the patients. To minimize bias related to patient non-blinding, however, no indications about the presumed superiority of one intervention over the others will be provided to the patients.
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| Occupational therapy | Other | 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. |
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| 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. |
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| 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). | 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). | 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). | 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) | 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). | 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) | 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) | 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) | 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) | 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) | 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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| D013812 |
| Therapeutics |