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临床试验/NCT04642248
NCT04642248Unknown1 期

A Comprehensive Analysis for Identification of Risk Factors for Running-Related Injuries

ACE Running LLC0 个研究点目标入组 1,500 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
1 期
入组人数
1,500
主要终点
Running Related Injury

研究概览

简要总结

At a basic level, running-related injuries (RRI) occur because the forces acting on the body exceed the capacity of the tissue to absorb the forces causing a breakdown of the tissue. When looking at ways to reduce RRI, the general strategy should be to make the body's ability to absorb forces greater than the forces acting on it. This can be accomplished by improving flexibility, increasing strength, reducing participation, improving recovery, and finally improving running form through gait retraining. Due to constraints of research by the ability to get large enough data sets, most literature has looked at one of these ways to make the forces manageable for a runner, while there are many ways. Running is not the only time that the body absorbs forces. This is especially true in a military population where there is a cumulative effect of forces from marching with heavy load, prolonged standing, and limited recovery.

Gait retraining has been shown to reduce injury rates by as much as 60%. Two studies have looked specifically at military populations to show that gait retraining can be effective for reducing a common injury in the shin. Military studies have also shown that gait retraining is transferable to wearing boots, even when the gait retraining is done in shoes. In the commercial sector, many studies have shown the benefit of changing running form with cadence modification, increasing forward lean, reducing collapsing at the knee, and modifying the position of the foot when the foot hits the ground. The aim of this study is taking the best evidence from gait retraining efforts and personalize the methodology to the individual runner. No study to date has provided individual recommendations for gait retraining, nor has the capabilities to do so that this portable 3D motion analysis system provides. The results can be used on a large scale to have a significant reduction in RRI and a monumental benefit to society.

详细描述

The total project will last 12 months, with 3 months to prepare testing facilities and train personnel, 6 months to analyze enough subjects for statistical power, and 3 months of statistical analysis and review. Between three to eleven Air Force Reserve bases with a Developmental Training Flight (DTF) will be given a RunDNA 3D Motion Analysis system to participate as testing facilities. The DTF is part of the Air Force Reserves where new recruits undergo education and training prior to BMT. Three to five Exercise Physiologists at each DTF base will be trained on how to perform the RunDNA analysis. Training will be done remotely, which has already successfully been done through video-based lectures at 6 Air Force bases. Each research examiner will pass a test and must submit a 3D analysis done with the RunDNA device prior to testing for standardization of procedures.

Each DTF has upwards of 100 military recruits who are preparing to attend BMT at any given time. Recruits will undergo baseline fitness testing when they are within 16 weeks of attending BMT. Fitness testing is comprised of a timed mile and a half run, two-minute timed pushup test, and two-minute timed sit up test. Three days or less after Fitness Testing (once any soreness has resolved), the recruits will undergo the RunDNA Analysis.

The RunDNA analysis consists of a Running Readiness Assessment (RRA) to determine mobility and strength and a 3D gait analysis to assess running form. The RRA is comprised of thirteen movement-based assessments that are scored with specific criteria for each test. The tests are:

  1. Toe Touch
  2. Back Bend
  3. Rotation
  4. Single Leg Balance - Eyes Closed
  5. Squat
  6. Single leg sit to stand
  7. Unilateral Hip Bridge Endurance Test
  8. Single Leg Calf Raise
  9. Side Plank
  10. Toe Splay
  11. Hallux Extension
  12. Hallux Abduction
  13. Ankle Range of Motion Items 1 through 5 have additional break downs to further identify limitations in movement and prescribe specific corrective exercise programs. DTF site personnel will enter the RRA results into the RunDNA mobile app at the time of administration. A scoring system has been created for a total of 55 points, where 1 point is given for a strength limitation, 2 points for a mobility limitation, and 3 points for painful movement. Each runner will be given a score from their RRA.

The 3D running analysis will use a portable device mounted on a tripod five feet behind a treadmill. There are 3 optical motion capture cameras with LED lights in each device. Eighteen reflective markers will be adhered to each runner using the modified Helen Hayes protocol. Runners will be given a minimum of 2 minutes to warm up, and then 15 seconds of running will be captured. After the quality of the 3D capture has been verified, each runner will be assigned a running category determined by the software. The software will communicate the running category with the mobile app and the groups that are being prescribed exercises will have those programs added to their profile.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Attending Basic Military Training

排除标准

  • No active or past injury within 6 months that precluded them from participating in physical activity or that they sought medical attention for; No medical profile that excludes them from running

结局指标

主要结局

Running Related Injury

时间窗: Up to 24 weeks from DTF to Completion of BMT

A daily questionnaire will be filled out by participants. There are four questions that identify injury status, pain, perceived ability to perform at their best, and changes in daily activities that may relate to injury or performance. Participants that answer "no" to the Question: "Are you physically able to run today" will be assessed for injury status and this will be monitored during the study.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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