- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07784998
Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis (GSMGWBP)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Knee osteoarthritis (KOA) is a common degenerative joint disorder associated with pain, impaired physical function, reduced proprioception, decreased mobility, and poor quality of life. Physiotherapy plays a central role in the conservative management of KOA by reducing pain and improving functional performance. Sensory-Modulated Graded Weight-Bearing Physiotherapy (SMGWBP) integrates sensory stimulation with progressive weight-bearing exercises to enhance neuromuscular control, balance, proprioception, and functional recovery.
This comparative experimental study aims to evaluate the effectiveness of SMGWBP in individuals with Kellgren-Lawrence grade II or III knee osteoarthritis and to compare treatment outcomes between male and female participants. A total of 52 participants will be recruited through purposive sampling. All participants will receive a standardized 6-week physiotherapy program consisting of three supervised sessions per week.
Outcome assessments will be performed at three time points: baseline (pre-intervention), mid-intervention (3 weeks), and post-intervention (6 weeks). The primary and secondary outcome measures include pain intensity measured using the Visual Analog Scale (VAS), physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), proprioception using the Joint Position Sense (JPS) test, gait performance using the Six-Minute Walk Test (6MWT), health-related quality of life using the Short Form-36 (SF-36), and treatment compliance. The study will examine changes in these outcomes over time and compare the effectiveness of the intervention between male and female participants.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Punjab Province
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Gujar Khan, Punjab Province, Пакистан
- Рекрутинг
- T.H.Q hospital
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Контакт:
- Dr.Sarmaad Kayyani, MBBS
- Номер телефона: +923005088112
- Электронная почта: Sarmaadkayyani@gmail.com
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Главный следователь:
- Sadia Akhtar, DPT
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion criteria
- Participants are eligible for inclusion if they meet the following criteria:
- Age between 40 and 60 years.
- Diagnosed with Grade II or Grade III Knee Osteoarthritis according to Kellgren-Lawrence Classification.
- Ability to ambulate independently without assistive devices.
- Mild to moderate pain intensity with a Visual Analogue Scale score less than seven.
- Ability to understand and follow instructions.
- Willingness to participate and provide written informed consent. Exclusion Criteria
- Participants are excluded if they meet any of the following criteria:
- History of knee surgery within the previous six months.
- Neurological disorders affecting balance, gait, or proprioception.
- Severe cardiovascular disease limiting participation in exercise.
- Rheumatoid arthritis or other inflammatory arthritic conditions.
- Severe cognitive impairment.
- Any medical condition that contraindicates participation in rehabilitation exercises.
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 |
|---|---|
|
Экспериментальный: Arm 1 - Arm Title: Male Participants
Twenty-six male participants with knee osteoarthritis will receive the Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme for six weeks, with three supervised sessions per week.
Outcomes will be assessed at baseline, Week 3, and Week 6.
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A structured six-week Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme consisting of three supervised sessions per week (18 sessions total).
Each session includes warm-up, sensory modulation, proprioceptive training, graded weight-bearing strengthening, functional mobility exercises, and cool-down activities.
The programme progresses through three phases: Weeks 1-2 focus on sensory activation and proprioceptive training; Weeks 3-4 on graded weight-bearing strengthening; and Weeks 5-6 on functional weight-bearing integration.
Exercises are progressed according to participant tolerance, pain severity, and functional performance.
Both male and female groups receive the same intervention.
|
|
Экспериментальный: Arm 2 - Arm Title: Female Participants
Twenty-six female participants with knee osteoarthritis will receive the Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme for six weeks, with three supervised sessions per week.
Outcomes will be assessed at baseline, Week 3, and Week 6.
|
A structured six-week Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme consisting of three supervised sessions per week (18 sessions total).
Each session includes warm-up, sensory modulation, proprioceptive training, graded weight-bearing strengthening, functional mobility exercises, and cool-down activities.
The programme progresses through three phases: Weeks 1-2 focus on sensory activation and proprioceptive training; Weeks 3-4 on graded weight-bearing strengthening; and Weeks 5-6 on functional weight-bearing integration.
Exercises are progressed according to participant tolerance, pain severity, and functional performance.
Both male and female groups receive the same intervention.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Pain Intensity Measured by the Visual Analog Scale (VAS), 0-10; lower scores indicate less pain
Временное ограничение: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on pain intensity between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
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Change in Physical Function Measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale, 0-68; lower scores indicate better function
Временное ограничение: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on physical function between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
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Change in Knee Joint Proprioception Measured by the Joint Position Sense (JPS) Test (absolute repositioning error in degrees; lower values indicate better proprioception)
Временное ограничение: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on proprioception between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
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Change in mobility Measured by the Six-Minute Walk Test (6MWT), distance walked in meters; higher values indicate better gait performance
Временное ограничение: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on mobility between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36), 0-100; higher scores indicate better health-related quality of life
Временное ограничение: Baseline, Week 3, and Week 6
|
To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on health-related quality of life between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
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
Другие идентификационные номера исследования
- 189-26
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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