Effect of Untact Upper Extremity Rehabilitation Using a Smart Board for Late Subacute and Chronic Patients With Brain Disorder

Официальное название

A Multicenter Confirmation Clinical Trial of Untact Upper Extremity Rehabilitation Using Smart Board for Late Subacute and Chronic Patients With Brain Disorder - a Randomized Single-blinded Controlled Trial

Обзор

The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Board by comparing the effects between a group using the home-based Neofect Smart Board and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.

Вмешательства

• Устройство Home-based Neofect Smart board
  a total of 20 sessions of home-based upper limb rehabilitation training using the Neofect Smart board, with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeeks.
• Другое home-based occupational therapy
  a total of 20 sessions of home-based upper limb rehabilitation training using the workbook provided by the research team , with 30 minutes per session, 1 session per day, 5 days a week, for 4 weeeks.

Первичные конечные точки

• Improvement of uper limb score in Fugl-Meyer assessment [Срок оценки: Within 14 days before the intervention, within 2 days after intervention]

Критерии участия

Критерии включения

• Patients with neurological diseases aged 19 to 85 years old
• Patients with hemiparesis lasting for more than 3 months due to neurological diseases (stroke, traumatic brain injury, brain tumor) and impaired upper limb function
• Patients with shoulder flexor and adductor muscle strength of MRC grade 2 or higher
• Patients with shoulder extensor and abductor spasticity of MAS grade 1+ or lower
• Participants with sufficient cognitive function to understand the instructions from the researcher and the smart board, and to perform the tasks (K-MMSE ≥21)

Критерии исключения

• pre-existing significant neurogenic disorders
• major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia
• History of diseases that caused pain or muscle atrophy in the affected upper limb before the onset of the neurological disease, which interfered with rehabilitation
• Severe spasticity of the affected upper limb (Modified Ashworth Scale score ≥3)
• skin disorders or open wounds on the affected upper limb
• Amputation, fractures, or soft tissue-related diseases or injuries on the affected upper limb
• severe pain that interferes with rehabilitation of the affected upper limb (Numeric Rating Scale > 6)
• Inability to maintain a seated posture for more than 10 minutes, which is required for using the smart board
• Significant visual impairment to the extent that the screen cannot be recognized when using the smart board

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

South Korea · 1 центр

• Samsung medical center — Seoul

Идентификаторы

NCT: NCT06837363 · 2024-09-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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