Chronic Ankle InstabilityCAI-FLOSSNCT07667816
Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability
A study testing Exercise Training, Tissue Flossing at 150 mmHg and Tissue Flossing at 200 mmHg in people with Chronic Ankle Instability and Ankle Instability, run by Chengdu Sport University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Chronic Ankle Instability, Ankle Instability
- What is being tested?
- Exercise Training, Tissue Flossing at 150 mmHg and Tissue Flossing at 200 mmHg
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chengdu Sport University
Chengdu, Sichuan
Weiyang Zhang, +8615196279571, weiyangz@cdsu.edu.cn
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Ankle Instability, Ankle Instability
- Being tested
- Exercise Training, Tissue Flossing at 150 mmHg, Tissue Flossing at 200 mmHg
- Keywords
- Tissue Flossing, Floss Band, Chronic Ankle Instability, Ankle Rehabilitation, Exercise Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
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.
Tissue Flossing at 150 mmHgDevice
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.
Tissue Flossing at 200 mmHgDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Exercise Training | Active comparator | Participants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression. Receives: Behavioral: Exercise Training |
| 150 mmHg Tissue Flossing Plus Exercise Training | Experimental | 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. Receives: Behavioral: Exercise Training; Device: Tissue Flossing at 150 mmHg |
| 200 mmHg Tissue Flossing Plus Exercise Training | Experimental | 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. Receives: Behavioral: Exercise Training; Device: Tissue Flossing at 200 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Limits of Stability Overall Directional Control Score
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.
Measured: Baseline and 6 weeks
Secondary outcomes (7)
Biodex Postural Stability Test Overall Stability Index
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.
Measured: Baseline and 6 weeks
Biodex Fall Risk Test Overall Stability Index
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.
Measured: Baseline and 6 weeks
Biodex Athlete Single-Leg Stability Test Overall Stability Index
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.
Measured: Baseline and 6 weeks
Active Ankle Dorsiflexion Range of Motion
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.
Measured: Baseline and 6 weeks
Maximum Isometric Ankle Eversion Strength
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.
Measured: Baseline and 6 weeks
FAAM Activities of Daily Living Subscale Score
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.
Measured: Baseline and 6 weeks
FAAM Sports Subscale Score
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: a control exercise group, a 150 mmHg tissue flossing plus exercise group, or a 200 mmHg tissue flossing plus exercise group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-yang Zhang, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667816
- Sponsor's protocol ID
- CSU-CAI-FLOSS-2025-01
- Other IDs
- 2025-128
- Acronym
- CAI-FLOSS
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07667816
- Acronym / sponsor ID
- CAI-FLOSS / CSU-CAI-FLOSS-2025-01
- Conditions
- Chronic Ankle Instability, Ankle Instability
- Keywords
- Tissue Flossing, Floss Band, Chronic Ankle Instability, Ankle Rehabilitation, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: a control exercise group, a 150 mmHg tissue flossing plus exercise group, or a 200 mmHg tissue flossing plus exercise group.
| Arm | Type | Receives |
|---|---|---|
| Control Exercise Training | Active comparator | Behavioral: Exercise TrainingParticipants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression. |
| 150 mmHg Tissue Flossing Plus Exercise Training | Experimental | Behavioral: Exercise Training, Device: Tissue Flossing at 150 mmHgParticipants 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. |
| 200 mmHg Tissue Flossing Plus Exercise Training | Experimental | Behavioral: Exercise Training, Device: Tissue Flossing at 200 mmHgParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingAll 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. | Behavioural | 150 mmHg Tissue Flossing Plus Exercise Training, 200 mmHg Tissue Flossing Plus Exercise Training, Control Exercise Training |
| Tissue Flossing at 150 mmHgDuring 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. | Device | 150 mmHg Tissue Flossing Plus Exercise Training |
| Tissue Flossing at 200 mmHgDuring 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. | Device | 200 mmHg Tissue Flossing Plus Exercise Training |
Primary outcome
Biodex Limits of Stability Overall Directional Control Score
Time frame: 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.
7 secondary outcomes
Biodex Postural Stability Test Overall Stability Index
Time frame: Baseline and 6 weeks
Biodex Fall Risk Test Overall Stability Index
Time frame: Baseline and 6 weeks
Biodex Athlete Single-Leg Stability Test Overall Stability Index
Time frame: Baseline and 6 weeks
Active Ankle Dorsiflexion Range of Motion
Time frame: Baseline and 6 weeks
Maximum Isometric Ankle Eversion Strength
Time frame: Baseline and 6 weeks
FAAM Activities of Daily Living Subscale Score
Time frame: Baseline and 6 weeks
FAAM Sports Subscale Score
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training, Tissue Flossing at 150 mmHg and Tissue Flossing at 200 mmHg in people with Chronic Ankle Instability and Ankle Instability, run by Chengdu Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiyang Zhang (15196279571, weiyangz@cdsu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Limits of Stability Overall Directional Control Score (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.