Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability (CAI-FLOSS)
21. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Weiyang Zhang
- Telefonnummer: 15196279571
- E-post: weiyangz@cdsu.edu.cn
Studiesteder
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Sichuan
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Chengdu, Sichuan, Kina
- Chengdu Sport University
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Ta kontakt med:
- Weiyang Zhang
- Telefonnummer: +8615196279571
- E-post: weiyangz@cdsu.edu.cn
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Eksperimentell: 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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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Biodex Limits of Stability Overall Directional Control Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Biodex Postural Stability Test Overall Stability Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Adverse Events During the 6-Week Intervention
Tidsramme: 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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Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
6. juni 2026
Først innsendt som oppfylte QC-kriteriene
21. juni 2026
Først lagt ut (Faktiske)
25. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSU-CAI-FLOSS-2025-01
- 2025-128 (Annen identifikator: Chengdu Sport University Ethics Committee)
Plan for individuelle deltakerdata (IPD)
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