Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction (BFR-PTTD)
Effects of Blood Flow Restriction Training on Dynamic Postural Stability and Proprioception in Post-Menopausal Women With Posterior Tibial Tendon Dysfunction: A Randomized Controlled Trial
Posterior tibial tendon dysfunction (PTTD) is a common musculoskeletal disorder characterized by pain, impaired foot function, and reduced dynamic stability. As one of the primary causes of adult-acquired flatfoot deformity, it can significantly affect walking ability, balance, and overall performance of daily activities. Although conventional rehabilitation typically emphasizes strengthening the posterior tibial tendon and surrounding muscles, these interventions may not fully address deficits in neuromuscular control and postural stability, highlighting the need for additional therapeutic approaches.
This randomized controlled trial aims to evaluate whether incorporating blood flow restriction (BFR) training into a rehabilitation program provides additional benefits for postmenopausal women with Stage I or flexible Stage II PTTD. A total of 54 eligible participants will be randomly allocated to either a BFR training group or a conventional exercise group. Clinical outcomes will be assessed before and after the intervention, including dynamic postural stability measured with the Biodex Balance System and active and passive ankle joint position sense assessed using the Biodex Isokinetic Dynamometer.
Обзор исследования
Статус
Подробное описание
Posterior tibial tendon dysfunction (PTTD) is a progressive musculoskeletal disorder that affects the integrity and function of the posterior tibial tendon, leading to pain, impaired foot support, decreased postural stability, and functional limitations. As one of the most common causes of adult-acquired flatfoot deformity, PTTD can substantially interfere with walking, balance, and other daily activities. The condition is particularly prevalent among middle-aged and older women. In postmenopausal women, age-related declines in muscle strength, tendon quality, and neuromuscular function may further compromise lower-limb stability and physical performance.
Blood flow restriction (BFR) training has emerged as a promising rehabilitation technique in which low-load resistance exercise is performed while a pneumatic cuff applies controlled pressure to the proximal portion of the limb. By partially restricting blood flow during exercise, this approach enables individuals to achieve training adaptations that are typically associated with higher exercise intensities while using considerably lower loads. Although BFR has shown encouraging results in the rehabilitation of various musculoskeletal conditions, its effectiveness in individuals with PTTD, particularly postmenopausal women, has not been adequately investigated.
This randomized controlled trial aims to compare the effects of a rehabilitation program incorporating blood flow restriction training with those of a conventional rehabilitation exercise program in postmenopausal women with Stage I or flexible Stage II posterior tibial tendon dysfunction. Eligible participants will be randomly assigned to one of the two intervention groups.
Outcome measures will be assessed at baseline and after completion of 4 weeks. The primary outcome will be dynamic postural stability, measured using the Biodex Balance System. Secondary outcomes will include active and passive ankle joint position sense assessed using the Biodex Isokinetic Dynamometer
The findings of this study are expected to expand the current evidence regarding the use of blood flow restriction training in the rehabilitation of posterior tibial tendon dysfunction. They may also help guide future evidence-based rehabilitation strategies aimed at improving functional outcomes and postural stability in postmenopausal women with this condition.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hajar M Edris, PhD
- Номер телефона: +201122243826
- Электронная почта: hajar.mohammed@muc.edu.eg
Места учебы
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Cairo Governorate
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Cairo, Cairo Governorate, Египет
- Faculty of Physical Therapy, May University in Cairo
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Контакт:
- Hajar M Edris, PhD
- Номер телефона: +201122243826
- Электронная почта: hajar.mohammed@muc.edu.eg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Female post-menopausal women aged 40-55 years.
- Clinically diagnosed with Stage I or flexible Stage II posterior tibial tendon dysfunction according to the Johnson and Strom classification modified by Myerson confirmed by an orthopedic physician.
- Symptoms persisting for ≥ 3 months.
- Pain intensity of ≥3/10 on the Visual Analogue Scale (VAS) during weight-bearing activities.
- Medically cleared to participate in blood flow restriction resistance training.
- Symptoms located at the medial ankle or foot.
- Pain on palpation of the posterior tibial tendon.
- A positive double and/or single heel-rise test.
- Able to walk independently without assistive devices
- Body Mass Index (BMI) between 18.5 and <24.9 kg/m².
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Rigidity of the hindfoot.
- Pain on palpation of the fibular muscles.
- History of corticosteroid injection in the tendon in a one-month period prior to the study onset.
- History of surgery to the hindfoot and/or ankle.
- History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either limb of the lower extremities.
- History of a fracture in either limb of the lower extremities requiring realignment.
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in interruption of desired physical activity.
- Hip joint or knee joint replacement.
- Patients who were possibly at risk of adverse reactions of blood flow restriction (i.e., poor circulatory system, obesity, diabetes, arterial calcification, sickle cell trait, severe hypertension, or renal failure).
- Any neurological conditions that affect proprioception, such as polyneuropathy, multiple sclerosis, and sensory ataxia.
- Vestibular deficits and vision problems.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Blood Flow Restriction Group
Participants receive a conventional physical therapy program combined with blood flow restriction.
Training
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Low-load Resistance exercise performed with a pneumatic cuff applied to the proximal lower extremities
Другие имена:
Strengthening Exercises and ankle support
Другие имена:
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Активный компаратор: Conventional Physical Therapy Group
Participants receive the same exercise program without blood flow restriction
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Strengthening Exercises and ankle support
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Overall Stability Index (OSI)
Временное ограничение: Baseline and immediately after completion of the 4-week intervention
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The Overall Stability Index (OSI) will be measured using the Biodex Balance System.
The OSI quantifies the overall variance of platform displacement from level during static balance testing and is expressed in degrees.
Lower OSI values indicate better postural stability.
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Baseline and immediately after completion of the 4-week intervention
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Anteroposterior Stability Index (APSI)
Временное ограничение: Baseline and immediately after completion of the 4-week intervention
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The Anteroposterior Stability Index (APSI) will be measured using the Biodex Balance System.
APSI quantifies postural sway in the sagittal (anteroposterior) plane during static balance testing and is expressed in degrees.
Lower APSI values indicate better balance control in the anteroposterior direction.
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Baseline and immediately after completion of the 4-week intervention
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Mediolateral Stability Index (MLSI)
Временное ограничение: Baseline and immediately after completion of the 4-week intervention
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The Mediolateral Stability Index (MLSI) will be measured using the Biodex Balance System.
MLSI quantifies postural sway in the frontal (mediolateral) plane during static balance testing and is expressed in degrees.
Lower MLSI values indicate better balance control in the mediolateral direction.
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Baseline and immediately after completion of the 4-week intervention
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Limits of stability (LOS)
Временное ограничение: Baseline and immediately after completion of the 4-week intervention
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Limits of Stability (LOS) will be assessed using the Biodex Balance System SD. LOS evaluates the participant's ability to voluntarily shift the center of gravity toward predefined targets while maintaining postural control.
Performance is expressed as an overall percentage score (%), with higher values indicating better dynamic balance and postural control.
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Baseline and immediately after completion of the 4-week intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Active Ankle Joint Position Sense
Временное ограничение: Baseline and immediately after completion of the 4-week intervention
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Active ankle joint position sense will be assessed using the Biodex Isokinetic Dynamometer during an active joint reposition test in the sagittal plane.
The outcome is expressed as the absolute angular repositioning error in degrees (°).
Lower values indicate better proprioceptive accuracy.
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Baseline and immediately after completion of the 4-week intervention
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Passive Ankle Joint Position Sense
Временное ограничение: Baseline and immediately after completion of the 4-week intervention
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Passive ankle joint position sense will be assessed using the Biodex Isokinetic Dynamometer during a passive joint repositioning test in the sagittal plane.
The outcome is expressed as the absolute angular repositioning error in degrees (°).
Lower values indicate better proprioceptive accuracy.
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Baseline and immediately after completion of the 4-week intervention
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Соавторы и исследователи
Спонсор
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MUC
Планирование данных отдельных участников (IPD)
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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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