- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07915141
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
The Effect of a Physiotherapy Program Developed for the Upper Extremity in Hemiplegic İndividuals on Daily Living aAtivities and Quality of Life.
This study aims to investigate the effects of an upper extremity physiotherapy program combined with home exercises on activities of daily living, quality of life, joint range of motion, and pain in individuals with hemiplegia following stroke.
The study compares two groups: participants receiving supervised physiotherapy in addition to a home exercise program and participants performing a home exercise program only. The intervention includes stretching, range-of-motion exercises, arm ergometer training, progressive strengthening, coordination exercises, and fine motor activities.
The intervention period lasts 10 weeks. Outcomes are assessed using the Barthel Index, Short Form-36 (SF-36), Visual Analog Scale (VAS), goniometric measurements, and sensory assessments.
The study aims to evaluate whether adding supervised physiotherapy to home exercises provides additional benefits for upper extremity rehabilitation following stroke.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Gülşen Yıldız, Bachelor of Science - Lisans
- Номер телефона: +90 551 220 29 09
- Электронная почта: gulsen.997178@gmail.com
Места учебы
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Istanbul, Турция (Туркие)
- Avrasya Hospital Gaziosmanpaşa and zeytinburnu
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Контакт:
- ali emre takkin, MsC
- Номер телефона: +90 507 154 48 87
- Электронная почта: aliemre.takkin@gmail.com
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Главный следователь:
- Gülşen Yıldız, BSc
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Istanbul, Турция (Туркие)
- Avrasya Hospital- Gaziosmanpaşa and Zeytinburnu
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Контакт:
- Ali Emre Takkin, MsC
- Номер телефона: +90 507 154 48 87
- Электронная почта: aliemre.takkin@gmail.com
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Главный следователь:
- Gülşen Yıldız, Bsc
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diagnosis of stroke.
- Age greater than 30 and less than 65 years.
- Time since stroke between 1 and 5 years.
- Voluntary participation in the study and treatment.
- Upper extremity Brunnstrom recovery stage 2 or 3.
- Ability to understand and perform the prescribed exercise program.
Exclusion Criteria:
- Unwillingness to continue participation in the study or treatment.
- Irregular attendance at scheduled treatment sessions.
- Upper extremity contracture severe enough to prevent exercise performance or range of motion assessment.
- Spasticity severe enough to prevent safe and effective upper extremity exercise performance.
- Failure to perform the prescribed home exercises regularly.
- Development of an additional disease or medical condition affecting upper extremity function during the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Physiotherapy and Home Exercise Group
Participants in this group receive supervised upper extremity physiotherapy twice a week for 45 minutes over 10 weeks, in addition to a home exercise program. The physiotherapy program includes stretching, passive and active-assisted range-of-motion exercises, arm ergometer training, progressive resistance exercises using Theraband and dumbbells, coordination exercises, and fine motor activities. The home exercise program is performed five days per week, twice daily for 30 minutes per session. |
Participants in the intervention group receive a 10-week rehabilitation program consisting of supervised upper extremity physiotherapy twice weekly for 45 minutes per session and a structured home exercise program on three non-treatment days per week. The home exercise program is identical in content to that of the control group and includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination training, and fine motor activities. Home exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. Supervised physiotherapy includes stretching, passive, active-assisted and active range-of-motion exercises, wand exercises, arm ergometer training, progressive strengthening using Theraband and 0.5 kg dumbbells, coordination exercises, and fine motor activities. Participants in the control group perform a structured home exercise program five days per week for 10 weeks. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. The exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. The content of the home exercise program is the same as that prescribed to the intervention group. No supervised physiotherapy sessions are provided to the control group. |
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Активный компаратор: Home Exercise Group
physiotherapy sessions. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. Exercises are performed five days per week, twice daily for 30 minutes per session, with 10 repetitions of each exercise. |
Participants in the control group perform a structured home exercise program five days per week for 10 weeks. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. The exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. The content of the home exercise program is the same as that prescribed to the intervention group. No supervised physiotherapy sessions are provided to the control group. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Barthel Index Score
Временное ограничение: Baseline (Week 1) and post-intervention (Week 10)
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The Barthel Index is used to assess independence in activities of daily living. Total scores range from 0 to 100, with higher scores indicating greater functional independence. Changes in Barthel Index scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Change in SF-36 Quality of Life Scores
Временное ограничение: Baseline (Week 1) and post-intervention (Week 10)
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The SF-36 is used to assess health-related quality of life across eight domains. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Changes in scores from baseline to the end of the 10-week intervention are compared between the two groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Upper Extremity Range of Motion (ROM)
Временное ограничение: Baseline (Week 1) and post-intervention (Week 10)
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Upper extremity range of motion is assessed using a goniometer. Measurements include shoulder flexion, extension and abduction; elbow flexion and extension; and wrist flexion and extension. Range of motion is recorded in degrees (°), with higher values indicating greater joint mobility. Changes from baseline to Week 10 are compared between the two groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Временное ограничение: Baseline (Week 1) and post-intervention (Week 10)
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Pain intensity is assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in VAS scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Change in Upper Extremity Sensory Function
Временное ограничение: Baseline (Week 1) and post-intervention (Week 10)
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Upper extremity sensory function is assessed using superficial, deep, and cortical sensory tests, including temperature discrimination, sharp-dull discrimination, joint position sense (proprioception), and stereognosis. Changes in sensory function from baseline to Week 10 are evaluated in both groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Hande B Besna Göçen, PhD, Istanbul Gelisim University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Цереброваскулярные расстройства
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Паралич
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Инсульт
- Гемиплегия
Другие идентификационные номера исследования
- STROKE-UE-2025-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Individual participant data will not be shared.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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