Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability (CAI-FLOSS)
21 июня 2026 г. обновлено: Wei-yang Zhang, Chengdu Sport University
Effects of Different Tissue Flossing Pressures Combined With Exercise Training on Ankle Function in Patients With Chronic Ankle Instability: A Three-Arm Randomized Controlled Trial
This study will evaluate whether tissue flossing with different pressure levels, when combined with exercise training, improves ankle function in young adults with chronic ankle instability.
Forty-eight participants will be randomly assigned to one of three groups: a control exercise group, a 150 mmHg tissue flossing plus exercise group, or a 200 mmHg tissue flossing plus exercise group.
All groups will complete the same 6-week rehabilitation program, three times per week.
Outcomes will be assessed at baseline and after the intervention, and long-term follow-up data will also be collected.
Обзор исследования
Статус
Еще не набирают
Подробное описание
Chronic ankle instability is characterized by recurrent ankle sprains, a feeling of giving way, pain, swelling, reduced function, and impaired balance control. Exercise-based rehabilitation is a cornerstone of nonoperative management, but adjunctive strategies that may enhance recovery remain of interest.
Tissue flossing is a compression-based intervention in which an elastic band is wrapped around the target joint or limb segment during exercise. It may influence mobility, neuromuscular control, proprioception, and symptom perception. However, the optimal pressure level for long-term rehabilitation in chronic ankle instability remains unclear.
This single-center, assessor-blinded, three-arm parallel randomized controlled trial will be conducted at Chengdu Sport University. A total of 48 young adults with chronic ankle instability will be allocated in a 1:1:1 ratio to a control exercise group, a 150 mmHg tissue flossing plus exercise group, or a 200 mmHg tissue flossing plus exercise group. All participants will complete the same 6-week rehabilitation program, with 3 sessions per week and 18 sessions in total. The two tissue flossing groups will receive pressure-calibrated flossing during the main training phase, while the control group will perform the same exercises without compression.
The primary outcome will be the change in Foot and Ankle Ability Measure Activities of Daily Living score from baseline to 6 weeks. Secondary outcomes will include sport-related foot and ankle function, functional movement screening, ankle range of motion, ankle isometric strength, Biodex balance-related measures, pain, long-term follow-up outcomes, adherence, and adverse events.
Тип исследования
Интервенционный
Регистрация (Оцененный)
48
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Weiyang Zhang
- Номер телефона: 15196279571
- Электронная почта: weiyangz@cdsu.edu.cn
Места учебы
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Sichuan
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Chengdu, Sichuan, Китай
- Chengdu Sport University
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Контакт:
- Weiyang Zhang
- Номер телефона: +8615196279571
- Электронная почта: weiyangz@cdsu.edu.cn
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Young adults aged 18 to 30 years.
- History of at least one recurrent ankle sprain or repeated episodes of ankle giving way in the affected limb.
- Subjective ankle instability, with or without pain, swelling, or activity limitation.
- Reduced balance ability, movement ability, or foot and ankle function on screening assessment.
- Symptoms lasting at least 6 months.
- No recent structured ankle rehabilitation before enrollment.
- No plan for vigorous additional exercise during the intervention period.
- Willing to participate and able to provide informed consent.
Exclusion Criteria:
- Latex allergy or intolerance to floss band material.
- Previous ankle dislocation, fracture, complete ligament rupture, or other severe structural injury.
- Most recent ankle sprain within 1 month before enrollment.
- Recent ankle surgery or acute ankle injury.
- Receipt of other ankle-related treatment, rehabilitation, or additional training during the study period.
- Diabetes, hyperlipidemia, or other conditions that may affect vascular status.
- Neurological disease, major musculoskeletal disease, vestibular disorder, visual disorder, or other lower-limb conditions that could affect assessment.
- Determined by the study physician or investigator to be unsuitable for participation.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
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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Активный компаратор: Control Exercise Training
Participants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression.
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All groups will perform the same supervised ankle rehabilitation program for 6 weeks, 3 sessions per week, 18 sessions in total, approximately 30 minutes per session.
The program will include warm-up, forward lunge ankle mobility training, resistance exercises for dorsiflexion, plantarflexion, inversion, and eversion using an elastic band, double-leg vertical jumping, single-leg balance training, and cool-down.
From week 4 onward, the balance task will be progressed to eyes-closed single-leg stance.
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Экспериментальный: 150 mmHg Tissue Flossing Plus Exercise Training
Participants will complete the same 6-week ankle rehabilitation exercise program as the control group, with tissue flossing applied to the affected ankle at 150 mmHg during the main training phase.
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All groups will perform the same supervised ankle rehabilitation program for 6 weeks, 3 sessions per week, 18 sessions in total, approximately 30 minutes per session.
The program will include warm-up, forward lunge ankle mobility training, resistance exercises for dorsiflexion, plantarflexion, inversion, and eversion using an elastic band, double-leg vertical jumping, single-leg balance training, and cool-down.
From week 4 onward, the balance task will be progressed to eyes-closed single-leg stance.
During the main exercise phase, tissue flossing will be applied to the affected ankle using an elastic floss band calibrated with a pressure gauge to 150 mmHg.
Wrapping will start distally over the dorsum of the foot and follow a figure-of-eight pattern covering the ankle joint region and extending to the distal lower leg.
The floss band will be removed immediately after training.
If numbness, severe pain, or pallor occur, the compression will be removed immediately.
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Экспериментальный: 200 mmHg Tissue Flossing Plus Exercise Training
Participants will complete the same 6-week ankle rehabilitation exercise program as the control group, with tissue flossing applied to the affected ankle at 200 mmHg during the main training phase.
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All groups will perform the same supervised ankle rehabilitation program for 6 weeks, 3 sessions per week, 18 sessions in total, approximately 30 minutes per session.
The program will include warm-up, forward lunge ankle mobility training, resistance exercises for dorsiflexion, plantarflexion, inversion, and eversion using an elastic band, double-leg vertical jumping, single-leg balance training, and cool-down.
From week 4 onward, the balance task will be progressed to eyes-closed single-leg stance.
During the main exercise phase, tissue flossing will be applied to the affected ankle using an elastic floss band calibrated with a pressure gauge to 200 mmHg.
Wrapping will start distally over the dorsum of the foot and follow a figure-of-eight pattern covering the ankle joint region and extending to the distal lower leg.
The floss band will be removed immediately after training.
If numbness, severe pain, or pallor occur, the compression will be removed immediately.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Biodex Limits of Stability Overall Directional Control Score
Временное ограничение: Baseline and 6 weeks
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Dynamic postural control will be assessed using the Biodex Balance System SD Limits of Stability Test.
Higher overall directional control scores indicate better balance control.
Change is calculated as the Week 6 score minus the baseline score.
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Baseline and 6 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Biodex Postural Stability Test Overall Stability Index
Временное ограничение: Baseline and 6 weeks
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Static postural stability will be assessed using the Biodex Balance System SD Postural Stability Test under eyes-open and stable-platform conditions.
Lower Overall Stability Index scores indicate better postural stability.
Change is calculated as the Week 6 score minus the baseline score.
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Baseline and 6 weeks
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Biodex Fall Risk Test Overall Stability Index
Временное ограничение: Baseline and 6 weeks
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Dynamic postural stability will be assessed using the Biodex Balance System SD Fall Risk Test.
Lower Overall Stability Index scores indicate better stability and lower fall-related balance risk.
Change is calculated as the Week 6 score minus the baseline score.
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Baseline and 6 weeks
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Biodex Athlete Single-Leg Stability Test Overall Stability Index
Временное ограничение: Baseline and 6 weeks
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Dynamic single-leg postural stability will be assessed using the Biodex Balance System SD Athlete Single-Leg Stability Test.
Lower Overall Stability Index scores indicate better single-leg stability.
Change is calculated as the Week 6 score minus the baseline score.
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Baseline and 6 weeks
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Active Ankle Dorsiflexion Range of Motion
Временное ограничение: Baseline and 6 weeks
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Active dorsiflexion range of motion of the involved ankle will be measured three times using a joint goniometer, and the mean value will be recorded in degrees.
Change is calculated as the Week 6 value minus the baseline value.
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Baseline and 6 weeks
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Maximum Isometric Ankle Eversion Strength
Временное ограничение: Baseline and 6 weeks
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Maximum isometric eversion strength of the involved ankle will be measured three times using a microFET3 handheld dynamometer, and the maximum value will be recorded in newtons.
Higher values indicate greater muscle strength.
Change is calculated as the Week 6 value minus the baseline value.
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Baseline and 6 weeks
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FAAM Activities of Daily Living Subscale Score
Временное ограничение: Baseline and 6 weeks
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Daily foot and ankle function will be assessed using the Foot and Ankle Ability Measure Activities of Daily Living subscale.
Scores are converted to a scale from 0 to 100, with higher scores indicating better function.
Change is calculated as the Week 6 score minus the baseline score.
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Baseline and 6 weeks
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FAAM Sports Subscale Score
Временное ограничение: Baseline and 6 weeks
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Sports-related foot and ankle function will be assessed using the Foot and Ankle Ability Measure Sports subscale.
Scores are converted to a scale from 0 to 100, with higher scores indicating better sports function.
Change is calculated as the Week 6 score minus the baseline score.
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Baseline and 6 weeks
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of Adverse Events During the 6-Week Intervention
Временное ограничение: During the 6-week intervention
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Adverse events occurring during the 6-week intervention will be recorded, including numbness, severe pain, pallor, swelling, increased pain, dizziness, shortness of breath, recurrent injury, and other unfavorable events.
Results will be reported as the number and percentage of participants experiencing at least one adverse event.
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During the 6-week intervention
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июля 2026 г.
Первичное завершение (Оцененный)
1 декабря 2026 г.
Завершение исследования (Оцененный)
1 мая 2027 г.
Даты регистрации исследования
Первый отправленный
6 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
21 июня 2026 г.
Первый опубликованный (Действительный)
25 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
25 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CSU-CAI-FLOSS-2025-01
- 2025-128 (Другой идентификатор: Chengdu Sport University Ethics Committee)
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .