Clinical trial NCT06959472: Impact of Hyperarch Fascia Training on Ankle Health and Exercise Performance
Official title: The Impact of Hyperarch Fascia Training on Ankle Sprain Pain and Exercise Performance in Athletic Men and Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Injuries
Sprains and Strains
Joint Instability
Keywords: ankle sprain
ankle injury
ankle pain
ankle instability
remote rehabilitation
countermovement jump
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives the Hyperarch Fascia Training (HFT) intervention.

The other group (control) continues their regular activity without the HFT program.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Change in Aggregate Score on Cumberland Ankle Instability Tool (CAIT)
timeFrame: Baseline (Week 0), Week 8, and Week 12
measure: Change in Aggregate Score on Foot and Ankle Ability Measure (FAAM)
timeFrame: Baseline (Week 0), Week 8, and Week 12
Secondary outcomes:
measure: Change in Countermovement Jump (CMJ) Performance
timeFrame: Baseline (Week 0), Week 8, and Week 12
measure: Change in Aggregate Score on Short Form Health Survey (SF-12)
timeFrame: Baseline (Week 0), Week 8, and Week 12
measure: Glute Activation via Elevated Towel Curls
timeFrame: Baseline (Week 0), Week 8, and Week 12
Other outcomes:
measure: Frequency and Nature of Adverse Events
timeFrame: Continuous throughout the 12-week intervention
Locations:
city: Tampa
country: United States
facility: Applied Science Performance Institute
state: Florida
Study officials:
affiliation: Applied Science & Performance Institute
name: Jacob Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.