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Идёт набор NCT07450274

Rehabilitation of Upper Limbs After Stroke

Без фазы С лечением Rehabilitation Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy..
Кому может быть актуально
Состояния в реестре: Rehabilitation, Stroke. Базовые параметры: 45 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of the Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke

Обзор

The aim of the research will be to evaluate the effects of upper limb rehabilitation using modern Pablo Tyromotion technologies in people after stroke in the late period.

Подробное описание

Prior to the study, an assessment of the reliability, reproducibility and validity of the devices among stroke individuals will be carried out.

The research will be conducted among people who have suffered a stroke in the late period.

The subjects will be allocated, by random selection, to two groups:

The study group will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Pablo Tyromotion device.

The control group will participate in conventional rehabilitation without biofeedback exercises.

Patients will undergo ongoing rehabilitation at the Donum Corde Rehabilitation and Medical Care Center (four weeks). The first examination will be performed on the day of admission, the second on the day of discharge, and the third (control) one month after discharge, during a follow-up visit.

Measurements will be performed three times for all participants:

* assessment of hand and finger muscle strength * calculated body mass index (BMI) * proprioceptive testing (mirror test, Thumb Location Test) * rehabilitation outcome assessment * functional capacity - Barthel Index, ADL * Ashworth muscle tone (spasticity) * hand dexterity using the Box and Blocks test * hand grip function according to the Frenchay scale * motor function of the hand and upper limb according to the Fugl-Meyer Motor Assessment Scale for Upper Extremity

Вмешательства

  • Другое Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.
    Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. The rehabilitation program will last 4 weeks from Monday to Friday.

Первичные конечные точки

  • Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Срок оценки: First examination - before the start of the rehabilitation program]
  • Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Срок оценки: Second examination - at the end of the three-week program]
  • Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Срок оценки: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
Вторичные конечные точки (12)
  • Hand grip strength [Срок оценки: First examination - before the start of the rehabilitation program]
  • Hand grip strength [Срок оценки: Second examination - at the end of the three-week program]
  • Hand grip strength [Срок оценки: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
  • pinching strength of the fingers [Срок оценки: First examination - before the start of the rehabilitation program]
  • pinching strength of the fingers [Срок оценки: Second examination - at the end of the three-week program]
  • pinching strength of the fingers [Срок оценки: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
  • Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Срок оценки: First examination - before the start of the rehabilitation program]
  • Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Срок оценки: Second examination - at the end of the three-week program]
  • Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Срок оценки: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
  • Manual skills, assessed with Box and Blocks test; [Срок оценки: First examination - before the start of the rehabilitation program]
  • Manual skills, assessed with Box and Blocks test; [Срок оценки: Second examination - at the end of the three-week program]
  • Manual skills, assessed with Box and Blocks test; [Срок оценки: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]

Критерии участия

Критерии включения

  • informed, voluntary consent of the patient
  • age 45-80 years
  • elementary (basic) gripping ability
  • degree of paresis of the upper limb and hand 4 -5 on the Brunnström scale
  • degree of disability on the Rankin scale 3
  • spastic tension of the upper limb, paresis hand not more than 3 on the modified Ashworth scale
  • current health condition confirmed by a medical examination, allowing participation in tests and exercises

Критерии исключения

  • lack of informed, voluntary consent of the patient
  • second or subsequent stroke, hemorrhagic stroke, stroke of the brainstem and cerebellum
  • disorders of higher mental functions limiting comprehension and carrying out tasks during exercises
  • visual field disturbances
  • mechanical and thermal injuries that may limit the grasping function of the hand
  • concomitant neurological, rheumatological and orthopedic diseases, including permanent - contractures that may affect the grasping ability and locomotion
  • unstable medical condition
  • failure to complete a 3-week rehabilitation stay

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • University of Rzeszów — Rzeszów

Идентификаторы

NCT: NCT07450274 · Neurorehabilitation upper limb

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗