Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04642248 |
| Other study ID # |
Pre-BMT Run |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
ACE Running LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Research participants (recruits) will also fill out information on demographics, running
experience, and injury history under their profile in the mobile application.
Investigators will randomly assigning which participants will be getting the intervention
program at the DTF sites to prescribe personalized programs based off the RunDNA analysis.
Examiners will assign the program based off of the user id that is generate, where odds will
be give the intervention and evens will not. The prescription of the programs is standardized
by using the mobile app to analyze the runner's results and prescribe one corrective exercise
program from the RRA, one gait category program, and one fitness training program. The gait
category program will be one of twelve programs that classify runners after the software
analyzes all running variables. Each category has specific warm up exercises, specific
drills, and specific gait retraining methods to lower the risk of injury for runners by
improving their form. An example category is an overstrider cadence program. This person
lands with the foot too far in front of the body because they have a slow step rate. The
overstrider cadence program includes a dynamic warm up, drills using a higher step rate, and
gait retraining where the runner matches their footsteps to a metronome that is 5-10% higher
than their self-selected step rate.
Recruits will go through a minimum of 8 weeks of training at DTF using the mobile app and GPS
watches to track compliance and training loads. The training program utilizes motor learning
principles to gradually increase the time a runner uses the new form with faded feedback to
allow for a natural adoption of the running technique. Cross training is included for
cardiovascular fitness, as well as speed work for running in the later stages of the program
to improve performance. Within 2 weeks of the recruit going to BMT, site personnel will
readminister the Fitness Tests and RunDNA Analysis using the same procedures listed above to
monitor changes in fitness, mobility, strength, and running form. Results will be recorded in
the RunDNA app for analysis.
All recruits will be monitored through the mobile application during BMT to assess Fitness
Test performance, injury rates, utilization of medical services, graduation rate, and
subjective pain and fatigue reports. Recruits will continue to wear the GPS device to track
training load. A daily subjective questionnaire will be filled out by the recruits on their
issued iPad reporting on injury status and syncing the watch's training data. If iPads are
not available to use the RunDNA app for each recruit, an analogue journal will be provided
that has their research subject number in the journal. Each recruit will be given their
subject number to know which journal is theirs. At the end of BMT the journals will be mailed
to be manually entered. If iPads are not available to use the RunDNA app, multiple iPads will
be sent to the medical staff at BMT and participants will come in twice weekly to sync their
GPS device with the iPad to load up training data from the GPS.
There will be no change in training plans from standard BMT protocols for recruits doing
through this research study. If at any point a recruit experiences injury or requests medical
attention the BMT medical staff will alert the Principle Investigator.
Statistical analysis will be done on all results to answer the primary research question,
with the anticipation of identifying key modifiable variables related to running injuries in
the control group and the intervention group's ability to reduce injury rates and boost
performance.
