Ankle InjuriesNCT06959472
Impact of Hyperarch Fascia Training on Ankle Health and Exercise Performance
A study testing Hyperarch Fascia Training in people with Ankle Injuries and Sprains and Strains, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Ankle Injuries, Sprains and Strains, Joint Instability
- What is being tested?
- Hyperarch Fascia Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Applied Science Performance Institute
Tampa, Florida, 33634
About this study
Official title: The Impact of Hyperarch Fascia Training on Ankle Sprain Pain and Exercise Performance in Athletic Men and Women
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.
Read the 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.
- Conditions
- Ankle Injuries, Sprains and Strains, Joint Instability
- Being tested
- Hyperarch Fascia Training
- Keywords
- ankle sprain, ankle injury, ankle pain, ankle instability, remote rehabilitation, countermovement jump
- Medical subject headings
- Ankle Injuries, Sprains and Strains, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperarch Fascia TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), Week 8, and Week 12
Secondary outcomes (3)
Change in Countermovement Jump (CMJ) Performance
The performance measures for CMJ will include: Jump height, flight time, force, velocity, and power. Testing will begin with a standardized warm-up consisting of two sets of 10 bodyweight squats, with ~30 seconds of rest between each set. After warming up, participants will perform two maximal CMJs at their perceived maximal effort, with the highest performance being used as the outcome score. Data collection will involve recording all jumps using a mobile phone camera mounted on a tripod to capture motion in the frontal plane. The recordings will utilize artificial intelligence algorithms for markerless motion tracking at 60 Hz with a resolution of 1080p, processed through the previously validated "My Jump Lab" mobile application. To register CMJ performance, participants will be instructed to place their hands on their hips, look directly at the camera, and remain steady until the recording begins and then perform a maximal CMJ.
Measured: Baseline (Week 0), Week 8, and Week 12
Change in Aggregate Score on Short Form Health Survey (SF-12)
The SF-12 measures quality of life across physical and mental health domains. Higher scores indicate better well-being .Question responses range from 1 to 5 or from 1 to 6 and each response is converted to a score from 0 to 100. For all questions, higher scores demonstrated greater well-being.
Measured: Baseline (Week 0), Week 8, and Week 12
Glute Activation via Elevated Towel Curls
Participants will self-assess glute activation following the performance of elevated towel curls. At the end of this exercise, subjects rate below on a scale of 1-10 how much they feel this exercise activates (causes muscular tension) in their glutes. With 1 being no glute activation (no glute muscle tension) and 10 being complete glute activation (extreme glute muscle tension).
Measured: Baseline (Week 0), Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start7 May 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives the Hyperarch Fascia Training (HFT) intervention. The other group (control) continues their regular activity without the HFT program.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Wilson, PhD, Principal investigator, Applied Science & Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959472
- Sponsor's protocol ID
- H030725
- Status last verified
- Feb 2026
- First submitted
- 28 Apr 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24814563Ware 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.
PubMed 8628042McKay 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.
PubMed 34965513Balsalobre-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.
PubMed 39771636
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hyperarch Fascia Training on Ankle Sprain Pain and Exercise Performance in Athletic Men and Women
- ClinicalTrials.gov ID
- NCT06959472
- Acronym / sponsor ID
- H030725
- Conditions
- Ankle Injuries, Sprains and Strains, Joint Instability
- Keywords
- ankle sprain, ankle injury, ankle pain, ankle instability, remote rehabilitation, countermovement jump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group receives the Hyperarch Fascia Training (HFT) intervention. The other group (control) continues their regular activity without the HFT program.
| Arm | Type | Receives |
|---|---|---|
| Hyperarch Fascia Training (HFT) Intervention Group | Experimental | Behavioral: Hyperarch Fascia TrainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperarch Fascia TrainingA 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. | Behavioural | Hyperarch Fascia Training (HFT) Intervention Group |
Primary outcome
Change in Aggregate Score on Cumberland Ankle Instability Tool (CAIT)
Time frame: Baseline (Week 0), Week 8, and Week 12
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.
Change in Aggregate Score on Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline (Week 0), Week 8, and Week 12
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.
3 secondary outcomes
Change in Countermovement Jump (CMJ) Performance
Time frame: Baseline (Week 0), Week 8, and Week 12
Change in Aggregate Score on Short Form Health Survey (SF-12)
Time frame: Baseline (Week 0), Week 8, and Week 12
Glute Activation via Elevated Towel Curls
Time frame: Baseline (Week 0), Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 24814563Wright 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.
- Background: PubMed 8628042Ware 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.
- Background: PubMed 34965513McKay 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.
- Background: PubMed 39771636Balsalobre-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Wilson, PhD principal investigator
Applied Science & Performance Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperarch Fascia Training in people with Ankle Injuries and Sprains and Strains, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aggregate Score on Cumberland Ankle Instability Tool (CAIT) (time frame: Baseline (Week 0), Week 8, and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06959472, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.