Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
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: Phono-Motor Therapy, Aerobic Exercise Training (AET), Stretching.
- Кому может быть актуально
- Состояния в реестре: Stroke, Aphasia, Reading Disorder. Базовые параметры: 18 лет — 85 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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Официальное название
Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment
Обзор
The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.
Подробное описание
Close to 2.5 million Americans are currently living with post-stroke aphasia, a debilitating communication disorder affecting multiple language modalities. Most stroke survivors with aphasia have acquired reading deficits, which persist chronically and severely limit life participation and autonomy. There is an urgent need for effective treatments grounded in stroke neurobiology which yield robust functional improvements. This project is a randomized controlled trial, which will recruit 70 individuals with chronic left-hemisphere stroke. Participants will complete 40 sessions of targeted reading treatment combined with either 20 minutes of moderate aerobic exercise or light stretching. Participants will undergo 3 Magnetic Resonance Imaging (MRI) scans, administered before the intervention, after the initial exercise session, and after the full course of treatment. They will also complete behavioral testing before and after the intervention. The outcome of this study has the potential to radically change how reading treatments are applied, increasing their effectiveness, and ultimately improving the lives of 2.5 million Americans living with stroke-related aphasia. In addition, it is likely that the results will contribute to the understanding of stroke recovery mechanisms thereby fundamentally advancing the field of neurorehabilitation.
Вмешательства
- Поведенческое Phono-Motor Therapy
The goal of PMT is to build orthographic and phonological awareness and phonological sequence knowledge. During PMT, participants will complete a series of tasks manipulating minimal sound units (consonants (C) \& vowels (V)), combining these units into syllables (CVC, CVCC, CCVC) and syllable sequences (real words and readable nonwords). PMT will aim to engage 5 modalities: visual, acoustic, tactile kinesthetic, motor, and orthographic. Multisyllabic stimuli used during treatment will consist o - Поведенческое Aerobic Exercise Training (AET)
Stationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down. - Поведенческое Stretching
Light stretching activities targeting the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.
Первичные конечные точки
- Reading Aloud [Срок оценки: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)]
- 2 Alternative Forced Choice Computer Tasks [Срок оценки: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)]
- Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2) [Срок оценки: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)]
- Cerebral Blood Flow (CBF) [Срок оценки: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)]
- Resting State Functional Connectivity (rsFC) [Срок оценки: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)]
- Task-induced fMRI activation [Срок оценки: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)]
Вторичные конечные точки (2)
- Western Aphasia Battery Revised [Срок оценки: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)]
- Philadelphia Naming Test (Short) [Срок оценки: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)]
Критерии участия
Критерии включения
- fluent and literate in English prior to stroke
- 1st ever stroke
- more than 3 months post-stroke
- post-stroke reading deficits, defined as reading aloud accuracy <83% for single words or <65% for readable nonwords
- living within a 50-mile radius from Kessler Foundation.
Критерии исключения
- contraindication to MRI
- prior neurological disease
- developmental learning or reading disability (i.e., developmental dyslexia)
- contraindication to exercise
- concurrent speech and language therapy
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Kessler Foundation — West Orange
Идентификаторы
NCT: NCT06213272 · R-1242-23