Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation
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: Co-treatment, Individual Treatment.
- Кому может быть актуально
- Состояния в реестре: Stroke, Stroke Acute. Базовые параметры: от 18 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a single center, pragmatic, randomized trial comparing the effectiveness of two commonly used approaches (co-treatment and individual treatment) in acute care rehabilitation.
Подробное описание
Individual and co-treatment are both widely used to deliver physical therapy (PT) and occupational therapy (OT) for patients admitted to the hospital for acute stroke. Studies have shown that patients with stroke who participate in hospital PT and OT have improved function upon discharge. However, there is a lack of evidence informing which patients are best suited for individual versus co-treatment, or which delivery method more effectively improves functional outcomes.
This gap in knowledge presents a unique opportunity to advance stroke rehabilitation. This study aims to compare the two approaches and their resulting functional outcomes through a randomized trial-an approach never previously undertaken-to determine whether individual or co-treatment leads to better patient recovery. The findings have the potential to optimize rehabilitation and the delivery of PT and OT for future patients with acute stroke.
Вмешательства
- Другое Co-treatment
Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization. - Другое Individual Treatment
Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.
Первичные конечные точки
- Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score [Срок оценки: Prior to discharge or at 28 days post-enrollment, whichever comes first.]
- Final Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Score [Срок оценки: Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.]
Вторичные конечные точки (1)
- Discharge Disposition [Срок оценки: At time of discharge.]
Критерии участия
Критерии включения
- Inpatient admission to the neurology stroke service AND
- Orders placed for both PT and OT within 96 hours of hospital admission
Критерии исключения
- Patient is known to be <18 years
- Patient is known to be a prisoner
- Patient is known to be pregnant
- Prior evaluation or treatment by PT and/or OT while admitted under the stroke service before study enrollment
- Clinician determines that either individual PT and OT or co-treatment is required or contraindicated for the optimal care of the patient
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Vanderbilt University Medical Center — Nashville
Публикации
- Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao PMID 38264914
- E Wurzinger H, Abzhandadze T, Rafsten L, Sunnerhagen KS. Dependency in Activities of Daily Living During the First Year After Stroke. Front Neurol. 2021 Nov 8;12:736684. doi: 10.3389/fneur.2021.736684. eCollection 2021. PMID 34819908
- Bernhardt J, Churilov L, Ellery F, Collier J, Chamberlain J, Langhorne P, Lindley RI, Moodie M, Dewey H, Thrift AG, Donnan G; AVERT Collaboration Group. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). Neurology. 2016 Jun 7;86(23):2138-45. doi: 10.1212/WNL.0000000000002459. Epub 2016 Feb 17. PMID 26888985
- Wang CY, Chen YC, Wang CH. Early Rehabilitation in Acute Care Inpatient Wards May Be Crucial to Functional Recovery 3 Months After Ischemic Stroke. Phys Ther. 2021 Jan 4;101(1):pzaa197. doi: 10.1093/ptj/pzaa197. PMID 33125475
- O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. PMID 497341
Идентификаторы
NCT: NCT07411534 · 251290