Impact of Hyperarch Fascia Training on Ankle Health and Exercise Performance

NCT ID: NCT06959472

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ankle Injuries Sprains and Strains Joint Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group receives the Hyperarch Fascia Training (HFT) intervention.

The other group (control) continues their regular activity without the HFT program.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Hyperarch Fascia Training

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Applied Science & Performance Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

Applied Science & Performance Institute

Locations

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Applied Science Performance Institute

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Charlie Ottinger, PhD

Role: CONTACT

813-867-8888

Gabe Wilson, PhD

Role: CONTACT

8138678888

Facility Contacts

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Charlie Ottinger, PhD

Role: primary

8138678888

Gabe Wilson, PhD

Role: backup

8138678888

References

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Wright CJ, Arnold BL, Ross SE, Linens SW. Recalibration and validation of the Cumberland Ankle Instability Tool cutoff score for individuals with chronic ankle instability. Arch Phys Med Rehabil. 2014 Oct;95(10):1853-9. doi: 10.1016/j.apmr.2014.04.017. Epub 2014 May 9.

Reference Type BACKGROUND
PMID: 24814563 (View on PubMed)

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

Reference Type BACKGROUND
PMID: 8628042 (View on PubMed)

McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.

Reference Type BACKGROUND
PMID: 34965513 (View on PubMed)

Balsalobre-Fernandez C, Varela-Olalla D. The Validity and Reliability of the My Jump Lab App for the Measurement of Vertical Jump Performance Using Artificial Intelligence. Sensors (Basel). 2024 Dec 10;24(24):7897. doi: 10.3390/s24247897.

Reference Type BACKGROUND
PMID: 39771636 (View on PubMed)

Other Identifiers

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H030725

Identifier Type: -

Identifier Source: org_study_id

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