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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperarch Fascia Training | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Nature of Adverse Events | Self-reported or observed adverse events will be recorded and assessed for severity, causality, and frequency across both groups. | Continuous throughout the 12-week intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Wilson, PhD | Applied Science & Performance Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Science Performance Institute | Tampa | Florida | 33634 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24814563 | Background | 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. | |
| 8628042 | Background | 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. |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D013180 | Sprains and Strains |
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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One group receives the Hyperarch Fascia Training (HFT) intervention.
The other group (control) continues their regular activity without the HFT program.
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| 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. | 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). | Baseline (Week 0), Week 8, and Week 12 |
| 34965513 | Background | 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. |
| 39771636 | Background | 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. |