- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07646431
Comparative Effects Of Clamshell And Short Arc Quadriceps Exercises In Patellofemoral Pain (CASCAPE-PFPS)
Comparative Effects Of Clam Shell Exercises And Short Arc Quadriceps Strengthening Exercises On Pain, Functional Disability And Quality Of Life In Patellofemoral Pain Syndrome
This is a research study to compare two different exercises for people who have patellofemoral pain syndrome. Patellofemoral pain syndrome means pain around or behind the kneecap, which is also called "runner's knee".
People in this study will be divided into two groups by chance. One group will do clamshell exercises. This exercise strengthens hip muscles. The other group will do short arc quadriceps exercises. This exercise strengthens thigh muscles near the knee. Both groups will do their exercises for the same number of weeks.
The main goal of this study is to see which exercise reduces knee pain better and helps patients do daily activities more easily. We will also check if quality of life improves after doing these exercises.
Pain level, knee function, and quality of life will be checked before starting exercises and again after finishing the exercise program.
The results may help doctors and physical therapists choose the best exercise for patients with kneecap pain.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This randomized parallel-group clinical trial will compare the effectiveness of clamshell exercises versus short arc quadriceps strengthening exercises in patients diagnosed with patellofemoral pain syndrome.
Study Design: Participants meeting inclusion criteria for patellofemoral pain syndrome will be randomly allocated into two intervention groups.
Group 1 - Clamshell Exercise Group: Participants will perform clamshell exercises targeting hip abductors and external rotators, specifically gluteus medius and gluteus maximus muscles.
Group 2 - Short Arc Quadriceps Group: Participants will perform short arc quadriceps strengthening exercises focusing on quadriceps femoris muscle, with emphasis on vastus medialis obliquus activation.
Intervention Duration: Both groups will follow supervised exercise protocols for [X weeks]. Frequency and repetitions will be as per standard protocol.
Outcome Measures:
Primary: Pain intensity using Visual Analog Scale, Functional disability using Kujala Anterior Knee Pain Scale, Quality of Life using SF-36 questionnaire.
Assessments will be conducted at baseline, mid-intervention, and post-intervention to compare changes between the two exercise groups.
Hypothesis: Clamshell exercises targeting hip muscles may show superior effects on pain and function compared to short arc quadriceps exercises in PFPS patients.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Punjab Province
-
Sargodha, Punjab Province, Пакистан, 40100
- Tehsil Headquarter Hospital, Bahlwal
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Patients diagnosed with Patellofemoral Pain Syndrome Age between 18-40 years. Male and female participants Presence of anterior knee pain for at least 4 weeks Pain aggravated by activities such as stair climbing, squatting, running, or prolonged sitting Willingness to participate and provide informed consent
Exclusion Criteria:
History of knee surgery or fracture around the knee joint Ligament injuries (e.g., ACL, PCL tears) or meniscal injuries Presence of other knee conditions (e.g., osteoarthritis, patellar dislocation). Neurological disorders affecting lower limb sensations and gait Current participation in any other physiotherapy or rehabilitation program Systemic inflammatory conditions (e.g., rheumatoid arthritis). Cognitive impairment or inability to follow instructions/attend sessions. Use of long-term steroids, strong analgesics, or anti-inflammatory medications.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Clamshell Exercise Group
Participants in this group will perform clamshell exercises targeting hip abductors and external rotators.
Exercise includes side-lying hip abduction with knees bent at 45 degrees, focusing on gluteus medius and gluteus maximus strengthening.
Sessions will be supervised by physical therapist for [X weeks], [frequency per week].
|
A hip strengthening exercise performed in side-lying position with hips and knees flexed.
Patient opens top knee like a clamshell while keeping feet together to strengthen gluteus medius and external rotators.
Другие имена:
|
|
Экспериментальный: Short Arc Quadriceps Exercise Group
Participants in this group will perform short arc quadriceps strengthening exercises targeting quadriceps femoris muscle with emphasis on vastus medialis obliquus activation.
Exercise performed from 30 to 0 degrees knee extension in short arc range.
Sessions will be supervised by physical therapist for [X weeks], [frequency per week].
|
A knee strengthening exercise performed in short range of motion from 30 degrees to full extension.
Patient extends knee against resistance while quadriceps muscle is activated, focusing on vastus medialis obliquus.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Pain Intensity
Временное ограничение: Baseline and 12 weeks post-intervention
|
Pain intensity will be assessed using Visual Analog Scale (VAS).
VAS is a 10cm horizontal line where 0 = no pain and 10 = worst pain imaginable.
Patients mark their current knee pain level.
Change in VAS score will be measured from baseline to post-intervention after completion of exercise program.
|
Baseline and 12 weeks post-intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Knee Function
Временное ограничение: Baseline and 12 weeks post-intervention
|
Knee function will be assessed using Kujala Anterior Knee Pain Scale (AKPS).
AKPS is a 13-item questionnaire specific for patellofemoral pain syndrome.
Total score ranges from 0 to 100, where 100 = no limitation and 0 = maximum limitation.
Change in AKPS score will be measured from baseline to post-intervention.
|
Baseline and 12 weeks post-intervention
|
|
Change in Quality of Life
Временное ограничение: Baseline and 12 weeks post-intervention
|
Quality of life will be assessed using Short Form-36 Health Survey (SF-36).
SF-36 includes 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health.
Scores range from 0 to 100 for each domain.
Change in SF-36 scores will be measured from baseline to post-intervention.
|
Baseline and 12 weeks post-intervention
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
Другие идентификационные номера исследования
- GIU/REC/26-40
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- КСО
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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