Rehabilitation With Biofeedback for People After 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: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices..
- 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 →
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Официальное название
Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke
Обзор
The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.
Подробное описание
Study participants will be randomly assigned to a study group and a control group.
* Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device * Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device * Control group - will complete a standard spa rehabilitation program without biofeedback exercises.
The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke.
Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit.
Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence.
Measurements will be performed three times for all participants:
* hand muscle strength assessment * 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 Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Patients in study groups I and II will also receive 30 minutes daily of hand biofeedback training using the Biometrics E-link device (group I) and hand biofeedback training using the Stella Bio device (group II).
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) - 3 months after hospital 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) - 3 months after hospital 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) - 3 months after hospital 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) - 3 months after hospital discharge, during a follow-up visit]
- Assessment of proprioception Thumb Localizing Test (TLT) [Срок оценки: First examination - before the start of the rehabilitation program]
- Assessment of proprioception Thumb Localizing Test (TLT) [Срок оценки: Second examination - at the end of the three-week program]
- Assessment of proprioception Thumb Localizing Test (TLT) [Срок оценки: Third study (flow-up) - 3 months after hospital 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: NCT07333079 · Stroke rehabilitation