Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Robotic therapy (Gloreha Sinfonia system)
  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
• Другое Occupational therapy
  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 strategie
• Поведенческое Control
  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.

Первичные конечные точки

• Manual dexterity [Срок оценки: 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).]

Вторичные конечные точки (11)

• Upper limb motor skills [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Don Carlo Gnocchi Onlus — Florence

Публикации

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• Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295. PMID 31834217
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• Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4. PMID 19261767
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• Cooke SF, Bliss TV. Plasticity in the human central nervous system. Brain. 2006 Jul;129(Pt 7):1659-73. doi: 10.1093/brain/awl082. Epub 2006 May 3. PMID 16672292

Идентификаторы

NCT: NCT06884553 · REDIRECT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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