Different Pressure Tissue Flossing Combined With Exercise for Chronic Ankle Instability

NCT07667816 | Not Yet Recruiting

• 2 other identifiers: CSU-CAI-FLOSS-2025-012025-128
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Ankle Instability; Ankle Instability

Keywords

Tissue Flossing; Floss Band; Chronic Ankle Instability; Ankle Rehabilitation; Exercise Therapy

Outcome Measures

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.

  Baseline and 6 weeks

Secondary Outcomes (7)

• Biodex Postural Stability Test Overall Stability Index

  Baseline and 6 weeks

• Biodex Fall Risk Test Overall Stability Index

  Baseline and 6 weeks

• Biodex Athlete Single-Leg Stability Test Overall Stability Index

  Baseline and 6 weeks

• Active Ankle Dorsiflexion Range of Motion

  Baseline and 6 weeks

• Maximum Isometric Ankle Eversion Strength

  Baseline and 6 weeks

Other Outcomes (1)

• Incidence of Adverse Events During the 6-Week Intervention

  During the 6-week intervention

Study Arms (3)

Control Exercise Training

ACTIVE COMPARATOR

Participants will complete a 6-week ankle rehabilitation exercise program, 3 sessions per week, without tissue flossing compression.

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.

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.

Behavioral: Exercise Training; Device: Tissue Flossing at 200 mmHg

Interventions

Exercise Training BEHAVIORAL

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.

150 mmHg Tissue Flossing Plus Exercise Training; 200 mmHg Tissue Flossing Plus Exercise Training; Control Exercise Training

Tissue Flossing at 150 mmHg DEVICE

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.

150 mmHg Tissue Flossing Plus Exercise Training

Tissue Flossing at 200 mmHg DEVICE

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.

200 mmHg Tissue Flossing Plus Exercise Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Sport University: lead

Study Sites (1)

Chengdu Sport University

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Weiyang Zhang

CONTACT

15196279571; weiyangz@cdsu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an assessor blinded to group allocation. Because the pressure intervention is perceptible, participants and the treating therapist will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)