Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability

Официальное название

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

Обзор

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.

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.

Вмешательства

• Поведенческое Exercise Training
  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 sta
• Устройство Tissue Flossing at 150 mmHg
  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.
• Устройство Tissue Flossing at 200 mmHg
  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.

Первичные конечные точки

• Biodex Limits of Stability Overall Directional Control Score [Срок оценки: Baseline and 6 weeks]

Вторичные конечные точки (7)

• Biodex Postural Stability Test Overall Stability Index [Срок оценки: Baseline and 6 weeks]
• Biodex Fall Risk Test Overall Stability Index [Срок оценки: Baseline and 6 weeks]
• Biodex Athlete Single-Leg Stability Test Overall Stability Index [Срок оценки: Baseline and 6 weeks]
• Active Ankle Dorsiflexion Range of Motion [Срок оценки: Baseline and 6 weeks]
• Maximum Isometric Ankle Eversion Strength [Срок оценки: Baseline and 6 weeks]
• FAAM Activities of Daily Living Subscale Score [Срок оценки: Baseline and 6 weeks]
• FAAM Sports Subscale Score [Срок оценки: Baseline and 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chengdu Sport University — Чэнду

Идентификаторы

NCT: NCT07667816 · CSU-CAI-FLOSS-2025-01 · 2025-128

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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