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NCT Number: NCT06884553

Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

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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Key information

Conditions

Chronic Stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Carlo Gnocchi Onlus

Florence, Italy, 50100

Location status: Recruiting

Location contact

Chiara Castagnoli, PT

CONTACT

[email protected]

3333738921

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Manual dexterity

    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).

    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)

Secondary outcomes

  1. Upper limb motor skills

    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).

    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).

  2. Manual dexterity and activities of daily living abilities

    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).

    ABILHAND questionnaire (Ekstrand et al., 2014) - Minimal Clinically Important Difference (MCID) ranges from 0.26 to 0.35 logits (Wang, 2011).

  3. Anxiety and depression

    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).

    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).

  4. Cognitive functioning screening

    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).

    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).

  5. Neglect

    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).

    Hearts Test (Mancuso et al., 2016)

  6. Health status and quality of life

    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).

    Short Form 12 (SF-12) (Gandek et al., 1998) - Minimal Clinically Important Difference (MCID) = 1.8-3.0 units (Fu et al., 2021).

  7. Shoulder/elbow/hand 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).

    Numeric Rating Scale (NRS) (Ferreira-Valente et al., 2011) ranging from 0 (no pain) to 10 (worst possible pain)

  8. Participation

    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).

    Frenchay Activity Index (FAI) (Antonucci et al., 2022)

  9. Perceived change

    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).

    Seven-level Likert scale (much worse, worse, somewhat worse, about the same, somewhat improved, improved, much improved) (Likert, 1932)

  10. Treatment satisfaction

    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).

    NRS 0-10 (Van Berckel et al., 2016)

  11. Neuroplasticity

    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).

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Castagnoli, PT

CONTACT

[email protected]

3333738921

Francesca Cecchi, MD

CONTACT

[email protected]

3388627184

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS

Registry information

Official study 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

Acronym: REDIRECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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