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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04642248
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 27, 2020
Air Force
Information provided by (Responsible Party):
ACE Running LLC

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Runner's Knee Other: Personalized Run Practice Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Comprehensive Analysis for Identification of Risk Factors for Running-Related Injuries
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Active Comparator: Non-intervention
This group will have the analysis and their data will be used to determine risk factors for developing running injuries.
Other: Personalized Run Practice
A combination of drills, flexibility, and strength activities combined with a gait retraining program

Experimental: Intervention
This group will get a personalized program based off of 3D and movement analysis results to judge the ability to reduce musculoskeletal injuries.
Other: Personalized Run Practice
A combination of drills, flexibility, and strength activities combined with a gait retraining program

Primary Outcome Measures :
  1. Running Related Injury [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Attending Basic Military Training

Exclusion Criteria:

  • 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
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Responsible Party: ACE Running LLC Identifier: NCT04642248    
Other Study ID Numbers: Pre-BMT Run
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No