Impact of Hyperarch Fascia Training on Ankle Health and Exercise Performance

This is a decentralized, randomized controlled trial evaluating the effects of Hyperarch Fascia Training (HFT) on pain and functional outcomes in adults aged 20-45 with a history of chronic ankle sprains. Up to 62 participants will be remotely recruited across the United States, with a target of 50 completing the study. Participants will be randomized to either an HFT intervention group or a passive control group, maintaining usual activity. The HFT group will complete three training sessions per week (one live virtual session and two self-guided sessions) over a 12-week period. Outcomes will assess pain and self-reported functional improvement using validated questionnaires and remote performance measures. All study activities, including recruitment, training, and assessments, will be conducted virtually.

Inclusion criteria

• Gender: Male or females
• Age: 20-45 years old
• History of Chronic Ankle Sprains has led to present symptoms such as current pain and/or instability during weight-bearing activities, but no reported chronic knee, hip, or groin issues (within the past 3-months).
• Cumberland Ankle Instability Tool (CAIT) score ≤ 25, indicating significant instability in at least one ankle (Wright et al. 2014).
• Participants will be either recreationally trained, or considered trained/developmental as defined by McKay et al. (2021). Specifically, recreationally trained will be defined as meeting the World Health Organization (WHO) minimum activity guidelines of: minimal activity of at least 150-300 minutes of moderate-intensity activity, or 75-150min of vigorous-intensity activity a week; plus, muscle-strengthening activities 2 or more days a week. Recreationally trained participants may also participate in multiple sports/forms of activity. Trained/developmental will be defined as regularly training ~3 times per week, identifying with a specific sport, training with a purpose to compete. There is no performance standard required for these tiers.
• Health Status: Free from chronic diseases, cardiovascular conditions, and musculoskeletal injuries unrelated to ankle sprains.
• Be willing to attend a weekly one hour virtual training session on HFT plus a written program to be performed individually in two sessions for an additional 2 hours per week performed on their own. In total, be willing to train for up to 3-5 hours weekly on ankle rehabilitation.
• Agree to maintain their usual activity levels and avoid additional treatment modalities for the duration of the study.
• Have a iPhone smart phone XR (2018), or later model
• Have a desktop computer or laptop, with a camera for video conference calls and online training.
• Have a location with a minimum of 10ft * 10ft space for exercise movement, and appropriate ceiling height for vertical jump testing.

Exclusion criteria

• History of Achilles tendon rupture or surgery within the last 12 months. Use of prescribed corticosteroids or other tendon-specific treatments within four weeks prior to the study.
• Current enrollment in any structured fascial or tendon rehabilitation programs.
• Pregnancy, breastfeeding, or plans to become pregnant during the study period.
• Any medical conditions that may interfere with running or exercise performance or study participation.
• Not willing to sign an NDA regarding the fascia training techniques used in this study
• Use of medical interventions, such as growth hormone or peptides, that may influence tissue adaptation to exercise.
• Current supplementation with common soft-tissue ingredients, such as glucosamine, chondroitin, methylsufonylmethane (MSM), or collagen protein.
• Presents with Ehlers-Danlos syndrome (EDS) or hypermobility History or current drug abuse
• History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
• Insulin-dependent diabetes and/or metformin use
• Chronic kidney or liver disease
• Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such conditions might be aggravated as a result of treatment
• Clinically diagnosed as depressed or taking depression or anti anxiety medication
• The investigator feels that for any reason the subject is not eligible to participate in the study
• History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
• Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
• Currently has been diagnosed with cancer or has been in remission for less than 1 year
• Participation in any other investigational study within 30 days prior to consent.