Impact of Hyperarch Fascia Training on Ankle Health and Exercise Performance

Study Purpose

The purpose of this clinical trial is to evaluate whether the Hyperarch Fascia Training (HFT) program can reduce ankle pain and improve jump performance in active adults aged 20-45 with a history of ankle sprains. Participants will be randomly assigned to either an HFT intervention group or a control group, maintaining regular activity. Over 12 weeks, participants will complete remote training sessions, track jump performance using the "My Jump Lab" app, and complete ankle pain and stability questionnaires. All activities and assessments will be conducted remotely with guidance from certified coaches.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06959472
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Applied Science & Performance Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jacob Wilson, PhD
Principal Investigator Affiliation Applied Science & Performance Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ankle Injuries, Sprains and Strains, Pain, Post-Traumatic, Joint Instability
Additional Details

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.

Arms & Interventions

Arms

Experimental: Hyperarch Fascia Training (HFT) Intervention Group

Participants in this group will undergo a 12-week Hyperarch Fascia Training (HFT) program targeting foot and ankle fascial health. The protocol includes one weekly live 1-hour virtual session with a certified HFT coach and two independent 1-hour training sessions.

No Intervention: Control Group - Activities of Daily Living (ADL)

Participants in the control group will be instructed to maintain their usual activities of daily living (ADL) over the 12-week study period. They will not engage in any structured intervention or new rehabilitation protocol.

Interventions

Behavioral: - Hyperarch Fascia Training

A 12-week behavioral intervention involving Hyperarch Fascia Training (HFT), which includes one weekly 1-hour virtual session with a certified coach and two 1-hour independent training sessions. The protocol combines meditation, mental imagery, foot and toe strengthening exercises, myofascial rolling, balance drills, and low-impact plyometrics.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Applied Science Performance Institute, Tampa, Florida

Status

Address

Applied Science Performance Institute

Tampa, Florida, 33634

Site Contact

Charlie Ottinger, PhD

[email protected]

8138678888