The Impact of Hyperarch Fascia Training on Ankle Sprain Pain and Exercise Performance in Athletic Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Aggregate Score on Cumberland Ankle Instability Tool (CAIT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hyperarch Fascia Training (Behavioral)
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.
结局指标
主要结局
Change in Aggregate Score on Cumberland Ankle Instability Tool (CAIT)
时间窗: 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)
时间窗: 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.
次要结局
- 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)