Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

NCT06884553 | Recruiting

• 1 other identifier: REDIRECT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

Robotic rehabilitation; occupational therapy; chronic stroke; upper limb impairment; biomarkers; manual dexterity

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (11)

• Upper limb motor skills

  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

  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

  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

  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

  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).

Study Arms (3)

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.

Device: Robotic therapy (Gloreha Sinfonia system)

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.

Other: Occupational therapy

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.

Behavioral: Control

Interventions

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.

Group A - Robotic therapy

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.

Group B - Occupational Therapy

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.

Group C - Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.

Sponsors & Collaborators

• University of Florence: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus

Florence, Italy, 50100, Italy

RECRUITING

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MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Francesca Cecchi, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

• Chiara Castagnoli, PT

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Cecchi, MD

CONTACT

3388627184; francesca.cecchi@unifi.it

Chiara Castagnoli, PT

CONTACT

3333738921; ccastagnoli@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a multicenter, prospective, randomized controlled trial (RCT) designed for nonprofit purposes and aimed at demonstrating superiority.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: March 19, 2025
• Study Start: September 19, 2023
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)