A01_-_PWS_Final-01.pdf

PERFORMANCE WORK STATEMENT

“In-field Gait Retraining to Reduce Reoccurrence of Lower Extremity Injuries”

12 April 2018

1. SCOPE:

1.1 Background: Musculoskeletal injuries are a leading cause of morbidity, lost training time, and reduced operational readiness in U.S. military forces (Hauret 2015, Ameida 1999). In 2007, musculoskeletal injuries resulted in approximately 2.4 million medical visits to military treatment facilities and accounted for $548 million dollars in direct patient care costs (Gregg

2007). Physical training and sports-related activities account for up to 90% of all injuries (Jones

1999 and Knapik 2007) and 80% of these injuries are considered overuse in nature. (Ameida

1999, Rudzki 1997, Jordaan 1994). In a one year prospective study of U.S. Army Soldiers, running was associated with 62% of the male physical training injuries, and 50% of the female physical training injuries (Knapik 2007).

Running is the primary method for physical endurance training in all four Military services

(Army, Navy, Air Force, and Marines). However, numerous overuse and/or misuse lower extremity injuries occur every year due to the accumulative effects of running. Therefore strategies aimed at reducing joint and tissue stress during running may be effective in reducing musculoskeletal injuries and increasing force readiness. Early identification of runners with a history of injury and performing gait retraining may reduce the healthcare burden to the

AMEDD, but also serve as a force multiplier by increasing readiness in the operational force, meeting the intent of both the Army Surgeon General and Army Chief of Staff.

Preventing and rehabilitating running injuries is a complex problem, particularly in the military where the unit sets running frequency, intensity, and duration rather than the individual. There is a growing body of research that demonstrates that in a lab setting, gait retraining is successful and results in long-term biomechanical changes that should reduce a runner’s risk for injury.

Recent research has also demonstrated the feasibility of gait retraining in healthy recreational runners that resulted in improved biomechanical factors. However, there is a need to determine if in-field gait retraining is feasible and beneficial in a military setting in order to reduce the burden of musculoskeletal injury on the MHS.

While an exact estimate of healthcare cost savings to the MHS by utilizing this type of technology in the proposed manner is difficult to quantify, we can make a conservative approximation using the following assumptions: 1) the average direct healthcare cost per visit for a musculoskeletal injury is $228 (Gregg 2007); 2) there are conservatively 250K military accessions annually (CNA report); and 3) Up to 40% of military trainees will sustain a musculoskeletal injury while in training, 90% of these will be running related and 80% of these will be overuse in nature (Rosendal,2003; Knapik, 2007; Almeida, 1999). This means approximately 72000 trainees will sustain an overuse running injury annually, culminating in

$16.4M in direct care costs for each trainee receiving a single medical visit. If we further assume that: 1) factors leading to injury in some runners are modifiable biomechanical factors associated with running form (Boyer 2015); and 2) modifying form in these runners will prevent an injury or re-injury from occurring, we can estimate that for every 1000 injuries prevented (1.4% of the total number of overuse musculoskeletal injuries anticipated in initial entry training), there is a savings of $228K in initial medical visits alone. This would mean that even if the proposed strategy had a meager success rate of 10% and were implemented only in the initial entry training environment, there would be a minimum savings of approximately $2.3M annually for the MHS.

Study Design:

This is a technology demonstration to evaluate the effectiveness of using wearable technology to retrain step rate in military personnel completing initial entry training and determine whether this retraining leads to a change in specified biomechanical variables (loading rates) and a reduction in overall injury rates. Once this objective has been successfully attained, we have future studies planned that will employ these technologies in larger units, such as

Brigade Combat Teams, within the Army for the purpose of injury prevention.

Setting:

All data collection will take place at the U.S. Army-Baylor University Doctoral Physical

Therapy Program at the AMEDD Center and School Joint Base San Antonio and the Center for the Intrepid, Brooke Army Medical Center. These facilities house more than 3000 square feet of laboratory space. These labs utilize instrumented treadmills and wearable accelerometers / gyroscopes (APDM Corporation, Portland Oregon) to quantify kinematic characteristics in both laboratory and free-living community mobility. The laboratory is supported by a full complement of analysis software including Mathworks MatLab, the Statistical Package for

Social Sciences (SPSS) and APDM’s Motion Studio. A sample of 100 military trainees with a history of lower extremity musculoskeletal injury from Fort Sam Houston, TX will be recruited for participation in the study.

Procedures:

A sample of 100 military trainees with a history of lower extremity musculoskeletal injury from Fort Sam Houston, TX will be recruited for participation in the study.

Inclusion criteria (all of the following)

1) Between the age of 18 - 50 years

2) Department of Defense beneficiaries

3) History of lower extremity, musculoskeletal injury within the last 90 days and completed a formalized walk to run progression

4) Read and speak English well enough to provide informed consent and follow study instructions

Exclusion criteria (any of the following)

1) Known pregnancy currently or in the previous 6 months

2) Lower extremity or low back surgery in the previous 6 months

3) Any lower extremity or low back exercise limiting profile

4) Participant has already completed a cadence gait retraining program

Volunteers meeting all inclusion and exclusion criteria will read and sign an informed consent form approved by the institutional review board (IRB). After consenting, each participant will answer a demographic questionnaire related to injury history and pertinent injury risk factors (location, duration and type of previous injury, profile time, height, weight, changes in menstruation, etc). They will then undergo a running analysis in which they will run on an instrumented treadmill and a video of their running form in the sagittal plane is captured using a stationary two-dimensional digital camera sampling at 240 Hz. Information collected from the treadmill will include AVLR of vGRF, while step frequency and other kinematic information will be collected from video analysis. Volunteers will run at their self-selected pace for five minutes on a treadmill, with cadence and AVLR analyzed during the last minute of running.

The same data collection procedure will be repeated after retraining and at 6 months to observe post intervention AVLR and step frequency.

Volunteers will then be placed into a retraining group and a control group. Each group will be provided Garmin Forerunner70 and Garmin Footpod to use while performing PRT with their unit and personal physical training. The retraining group will receive a watch and wireless accelerometer to use for monitoring their step rate with instructions to increase their preferred step rate by 7.5% over eight in-field training sessions Training units at FT. Sam Houston perform ability group or self-paced runs for the majority of their endurance training, so participants should not have difficulty adjusting their step rates IAW study plans. Willy et al. was successful using eight in-field training sessions to sustain a 7.5% increase in step rate 1 month post-training in healthy runners (Willy 2016). Adherence to step rate will be assessed via mobile monitoring.

The control group will receive the same device to monitor their pace but receive no instruction to change their preferred step rate. Volunteers will return after eight in-field training sessions using their monitoring device to alter step rate and at 6 months to re-assess AVLR and step frequency.

Data Analysis:

All data will be analyzed using the Statistical Package for the Social Sciences version 23.

Descriptive statistics will be calculated to describe the sociodemographic characteristics (age, height, weight, etc.) for each group. Means and standard deviations will be computed for continuous data and frequency distributions will be analyzed for categorical data.

Step frequency will be analyzed by a two-way, mixed model, repeated analysis of variance (ANOVA) [group (2) x time point (3)] with an α=0.05 and with a subsequent Holm-

Bonferroni correction.

Chi square analysis will be used to examine whether an increase in step rate is associated with fewer injuries 1 year after training.

Upon successful demonstration, the technology described below will be able to aid providers in a variety of settings from Medical centers to the Brigade Combat Teams for rehabilitation and injury prevention / human performance optimization.

1.2 Description of Effort: The Contractor shall provide input to the Government’s Principal

Investigator in the conduct of the project. The Contractor shall provide all equipment, supplies, materials, supervision, and other items and non-personal services necessary to perform except for those items specified as government furnished property and services.

1.3 Objectives:

1. To assess the effectiveness of using wearable technology (watch and footpod accelerometer) in performing gait retraining in field on military trainees.

2. To assess the effectiveness of step rate retraining on injury rates over one year.

1.4 Key Personnel: The Contractor shall provide the name of a Contract Manager responsible for the oversight of the performance herein. The name of this person and an alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the

Contracting Officer. The Contract Manager or alternate shall have full authority to act for the

Contractor on all matters relating to daily operation of this contract. The Contract Manager or alternate shall be available between 9:00 a.m. to 5:30 p.m. Pacific Standard Time, Monday thru

Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.5 Equipment/Supplies: The Contractor shall procure the following equipment:

Item Vendor Quantity

Garmin FR70 watches Garmin 100

Garmin Footpod Garmin 50

Inspiron Laptop Dell 1

Digital Camera, EX-ZR850 Casio 1

Wifi Hotspot and Service AT&T 1

1.6 Personnel: The contractor shall provide a study coordinator at 1.0 FTE located at the

AMEDD Center and School, San Antonio, TX. The Contractor shall ensure that the study coordinator is responsible for daily conduct of the protocol to include subject recruitment, data collection and reduction, with input to data analysis and reporting of findings.

2. Specific Tasks:

2.1. General Requirements:

2.1.1. The Contractor shall provide all necessary services of personnel, materials, supplies, equipment, professional services, and research administration for the effort defined herein.

2.2. Research Administration:

2.2.1. The Contractor shall ensure that Contractor personnel working at the site are properly credentialed.

2.2.2. The Contractor shall ensure that Contractor personnel working at the site meet the

Occupational Health and training requirements of the military site.

2.2.3. The Contractor shall provide input to the study through the Government’s

Principal Investigator. The Contractor shall maintain organized records and documentation for the administration, budget, and execution requirements of this effort. The contractor shall recruit, enroll, and consent subjects from Fort Sam

Houston. The contractor shall perform data collection by administering an intake questionnaire and performing gait analysis on an instrumented treadmill. The contractor shall administer the intervention by providing instruction on cadence retraining and the use of the foot pod and watch. The contractor shall perform monthly medical record review of the subjects. The contractor shall perform follow-up testing to include a questionnaire and gait analysis on an instrumented treadmill. The contractor shall perform data analysis upon the last data collection and entry for the last subject. The contractor shall provide input in the preparation of the manuscript and scientific presentations related to the study results.

2.2.4. The Contractor shall communicate with the Government’s research team(s) concerning the study/studies via email, team meetings, and phone contact.

3.0 CONTRACTOR MANPOWER REPORTING

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through

September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at: http://www.ecmra.mil.

The required information includes:

(1) Unit Identification Code (UIC) of the Army Requiring Activity that would be performing the mission if not for the contractor: ____________ (Enter the Army Requiring Activity’s UIC here).

(2) Command of the Requiring Activity that would be performing the mission if not for the contractor: __________ [Enter the Major Command (MACOM) of the Requiring Activity here].

(3) Contracting Officer (KO) and contact information:

(4) Contracting Officer’s Representative (COR) and contact information:

(5) Federal Service Code (FSC) reflecting services provided by contractor (and separate FSC for each subcontractor if different). If there are multiple FSCs for an Order number, enter a separate data record for each FSC.

(6) Location where contractor and subcontractor(s) perform the service, including the city, state, zip code, and country. When service is performed at an overseas location, state only the city and country. If there are multiple Locations for an Order number, enter a separate data record for each Location. (Note: If there are many location records that need to be entered, the Bulk Loader function is available which allows the transfer of information from a contractor’s system to the http://www.ecmra.mil/ http://www.ecmra.mil/ secure web site. The Bulk Loader Template and Bulk Loader Instructions may be downloaded from the web site.)

(7) Contractor Type (prime or subcontractor).

(8) Direct labor hours (including subcontractors) for each FSC.

(9) Direct labor dollars paid this reporting period (including subcontractors) for each FSC.

(10) Weapons system support indication: ________ (Enter yes or no).

If subcontractors are used in the performance of this contract, several factors must be considered.

Contractor shall include, and require inclusion of, this term in all subcontracts at any tier under the contract in which services are being procured. Contractor shall also enter their data in a timely manner, as subcontractors cannot input any information into the eCMRA system until the

Prime Contractor has entered their data. The Prime Contractor has overall responsibility for ensuring subcontractors enter their respective data. Subcontractors are only responsible for entering Location Data.