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

21 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Sichuan
      • Chengdu, Sichuan, Chine
        • Chengdu Sport University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control Exercise Training
Participants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression.
Comportemental: 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.
Expérimental: 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.
Comportemental: 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.
Dispositif: 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.
Expérimental: 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.
Comportemental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Biodex Limits of Stability Overall Directional Control Score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Biodex Postural Stability Test Overall Stability Index
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Incidence of Adverse Events During the 6-Week Intervention
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chengdu Sport University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

6 juin 2026

Première soumission répondant aux critères de contrôle qualité

21 juin 2026

Première publication (Réel)

25 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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