NCT06959472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 7, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

April 28, 2025

Last Update Submit

February 26, 2026

Conditions

Keywords

ankle sprainankle injuryankle painankle instabilityremote rehabilitationcountermovement jump

Outcome Measures

Primary Outcomes (2)

  • Change in Aggregate Score on Cumberland Ankle Instability Tool (CAIT)

    The CAIT is a 9-item self-reported questionnaire used to measure perceived ankle instability. Scores range from 0-30, with lower scores indicating greater instability.

    Baseline (Week 0), Week 8, and Week 12

  • Change in Aggregate Score on Foot and Ankle Ability Measure (FAAM)

    The FAAM assesses functional ability with two subscales: Activities of Daily Living (ADL) and Sports. Each item is scored from 0 (unable to perform) to 4 (no difficulty), with higher scores indicating better function.

    Baseline (Week 0), Week 8, and Week 12

Secondary Outcomes (3)

  • Change in Countermovement Jump (CMJ) Performance

    Baseline (Week 0), Week 8, and Week 12

  • Change in Aggregate Score on Short Form Health Survey (SF-12)

    Baseline (Week 0), Week 8, and Week 12

  • Glute Activation via Elevated Towel Curls

    Baseline (Week 0), Week 8, and Week 12

Other Outcomes (1)

  • Frequency and Nature of Adverse Events

    Continuous throughout the 12-week intervention

Study Arms (2)

Hyperarch Fascia Training (HFT) Intervention Group

EXPERIMENTAL

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.

Behavioral: Hyperarch Fascia Training

Control Group - Activities of Daily Living (ADL)

NO INTERVENTION

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

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.

Hyperarch Fascia Training (HFT) Intervention Group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science Performance Institute

Tampa, Florida, 33634, United States

Location

Related Publications (4)

  • 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.

    PMID: 24814563BACKGROUND
  • 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.

    PMID: 8628042BACKGROUND
  • 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.

    PMID: 34965513BACKGROUND
  • 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.

    PMID: 39771636BACKGROUND

MeSH Terms

Conditions

Ankle InjuriesSprains and StrainsJoint Instability

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Jacob Wilson, PhD

    Applied Science & Performance Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group receives the Hyperarch Fascia Training (HFT) intervention. The other group (control) continues their regular activity without the HFT program.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 6, 2025

Study Start

May 7, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations