NCT04642248

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

October 30, 2020

Last Update Submit

July 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Running Related Injury

    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.

    Up to 24 weeks from DTF to Completion of BMT

Study Arms (2)

Non-intervention

ACTIVE COMPARATOR

This group will have the analysis and their data will be used to determine risk factors for developing running injuries.

Other: Personalized Run Practice

Intervention

EXPERIMENTAL

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

Interventions

A combination of drills, flexibility, and strength activities combined with a gait retraining program

InterventionNon-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attending Basic Military Training

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 24, 2020

Study Start

November 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share