NCT04747223

Brief Summary

This study will be the first project to evaluate the effectiveness of wearable technology (Garmin Forerunner35) while performing gait retraining in field on military members. The watch will provide real time feedback to the runner on their step rate while performing running sessions outside of the lab. This allows the runner to modify their step rate to meet a recommended step rate provided by the study team member. Aim 1: To demonstrate the utility of wearable sensors to modify running step rate through real time biofeedback. Aim 2: To determine whether altering step rate using real time biofeedback reduces lower extremity musculoskeletal injury reoccurrence within 1 year post training.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

July 24, 2020

Last Update Submit

February 8, 2021

Conditions

Keywords

Running-related lower extremity overuse injuries

Outcome Measures

Primary Outcomes (3)

  • Change in Average vertical loading rate (AVLR)

    The slope of the line on a ground reaction force curve from initial contact to the impact peak

    Baseline, 10 weeks, 6 months

  • Change in Step rate (SR)

    The number of steps a participant takes per minute of running

    Baseline, 10 weeks, 6 months

  • Injury

    The number of lower extremity, over-use injuries sustained within 1 year after completing the ten in-field training sessions

    1 year

Secondary Outcomes (2)

  • Absolute risk reduction

    1 year

  • Limited duty days

    1 year

Study Arms (2)

Retraining (RT) Group

EXPERIMENTAL

The retraining group will receive a watch accelerometer to use for monitoring their step rate with instructions to increase their preferred step rate by 7.5% over the ten in-field training sessions.

Other: Run Gait Retraining

Control (CON) Group

NO INTERVENTION

The control group will receive the same device to monitor their pace but receive no instruction to change their preferred step rate over the ten in-field training sessions.

Interventions

Running step rate will be retrained by real-time biofeedback via a watch accelerometer. Recent literature showed that performing gait retraining by altering step rate reduces loading rates and joint stress that are associated with lower extremity injuries (Wilson et al 2014, Lenhart et al 2014, Heidersheit et al 2011).

Retraining (RT) Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the age of 18 - 50 years
  • Active Duty, Department of Defense beneficiaries
  • History of running-related overuse, musculoskeletal injury of the lower extremity (knee, hip, lower leg, or bone stress injury) within the last six months
  • Currently able to run continuously for at least 15 minutes at self-selected pace, 3 times per week.
  • Read and speak English well enough to provide informed consent and follow study instructions

You may not qualify if:

  • Known pregnancy currently or in the previous 6 months
  • Lower extremity or low back surgery in the previous 6 months
  • Any lower extremity or low back exercise profile that limits running
  • Participant has already completed a step rate, gait retraining program
  • Participant has a step rate greater than 176 steps per minute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Heiderscheit BC, Chumanov ES, Michalski MP, Wille CM, Ryan MB. Effects of step rate manipulation on joint mechanics during running. Med Sci Sports Exerc. 2011 Feb;43(2):296-302. doi: 10.1249/MSS.0b013e3181ebedf4.

    PMID: 20581720BACKGROUND
  • Willson JD, Ratcliff OM, Meardon SA, Willy RW. Influence of step length and landing pattern on patellofemoral joint kinetics during running. Scand J Med Sci Sports. 2015 Dec;25(6):736-43. doi: 10.1111/sms.12383. Epub 2015 Jan 14.

    PMID: 25585589BACKGROUND
  • Lenhart R, Thelen D, Heiderscheit B. Hip muscle loads during running at various step rates. J Orthop Sports Phys Ther. 2014 Oct;44(10):766-74, A1-4. doi: 10.2519/jospt.2014.5575. Epub 2014 Aug 25.

    PMID: 25156044BACKGROUND
  • Willy RW, Buchenic L, Rogacki K, Ackerman J, Schmidt A, Willson JD. In-field gait retraining and mobile monitoring to address running biomechanics associated with tibial stress fracture. Scand J Med Sci Sports. 2016 Feb;26(2):197-205. doi: 10.1111/sms.12413. Epub 2015 Feb 4.

    PMID: 25652871BACKGROUND

MeSH Terms

Conditions

Cumulative Trauma DisordersPatellofemoral Pain SyndromeMedial Tibial Stress Syndrome

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and InjuriesJoint DiseasesMusculoskeletal DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesLeg Injuries

Central Study Contacts

Jamie Morris, DPT, DSc

CONTACT

David Boland, DPT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants are masked to group assignment. Investigators are blinded to participant's group at follow-ups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

February 10, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 31, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share