Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorChengdu Sport University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Training
BehavioralAll 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 mmHg
DeviceDuring 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 mmHg
DeviceDuring 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Control Exercise TrainingActive comparator 1 intervention
Group B: 150 mmHg Tissue Flossing Plus Exercise TrainingExperimental treatment 2 interventions
Group C: 200 mmHg Tissue Flossing Plus Exercise TrainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 weeksSecondary outcomes
1
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.
Time frame
Baseline and 6 weeks2
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.
Time frame
Baseline and 6 weeks3
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.
Time frame
Baseline and 6 weeks4
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.
Time frame
Baseline and 6 weeksOther outcomes
1
Incidence of Adverse Events 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.
Time frame
During the 6-week interventionSponsors and contacts
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Source ClinicalTrials.gov
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