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Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability (CAI-FLOSS)

21 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Sichuan
      • Chengdu, Sichuan, Cina
        • Chengdu Sport University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control Exercise Training
Participants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression.
Comportamentale: 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 stance.
Sperimentale: 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.
Comportamentale: 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 stance.
Dispositivo: 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.
Sperimentale: 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.
Comportamentale: 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 stance.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biodex Limits of Stability Overall Directional Control Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biodex Postural Stability Test Overall Stability Index
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Adverse Events During the 6-Week Intervention
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chengdu Sport University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

6 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CSU-CAI-FLOSS-2025-01
  • 2025-128 (Altro identificatore: Chengdu Sport University Ethics Committee)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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