Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability (CAI-FLOSS)
21 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
48
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Weiyang Zhang
- Numer telefonu: 15196279571
- E-mail: weiyangz@cdsu.edu.cn
Lokalizacje studiów
-
-
Sichuan
-
Chengdu, Sichuan, Chiny
- Chengdu Sport University
-
Kontakt:
- Weiyang Zhang
- Numer telefonu: +8615196279571
- E-mail: weiyangz@cdsu.edu.cn
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Control Exercise Training
Participants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression.
|
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.
|
|
Eksperymentalny: 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.
|
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.
|
|
Eksperymentalny: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Biodex Limits of Stability Overall Directional Control Score
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Biodex Postural Stability Test Overall Stability Index
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
Biodex Fall Risk Test Overall Stability Index
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
Biodex Athlete Single-Leg Stability Test Overall Stability Index
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
Active Ankle Dorsiflexion Range of Motion
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
Maximum Isometric Ankle Eversion Strength
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
FAAM Activities of Daily Living Subscale Score
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
FAAM Sports Subscale Score
Ramy czasowe: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Adverse Events During the 6-Week Intervention
Ramy czasowe: During the 6-week intervention
|
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.
|
During the 6-week intervention
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 lipca 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2026
Ukończenie studiów (Szacowany)
1 maja 2027
Daty rejestracji na studia
Pierwszy przesłany
6 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
25 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
25 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CSU-CAI-FLOSS-2025-01
- 2025-128 (Inny identyfikator: Chengdu Sport University Ethics Committee)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .