Using Real Time Biofeedback to Alter Running Mechanics

March 4, 2024 updated by: Jamie Morris, Keller Army Community Hospital

Using Real Time Biofeedback to Alter Running Biomechanics

The purposes of this study are 1) to assess foot strike patterns initially, at six months and at one year between two groups of runners attempting to transition to a non-rearfoot strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Between the age of 18 - 50 years
  2. Run on average 12mi per week
  3. DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment
  4. Read and speak English well enough to provide informed consent and follow study instructions

Exclusion Criteria:

  1. Known pregnancy currently or in the previous 6 months
  2. Lower extremity or low back pain in the previous 3 months
  3. Lower extremity or low back surgery in the previous 6 months
  4. Any lower extremity or low back exercise limiting profile
  5. Previous stress fracture of the foot
  6. Participant who has a non-rearfoot strike running pattern

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Group does not receive the biofeedback sensor
Experimental: Biofeedback group
Group does receive the biofeedback sensor
Tibia accelerometer strapped to distal tibia to detect tibial shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Foot Strike Pattern From Baseline
Time Frame: Immediately post-training, 6mo post-training, and 1yr post-training
Foot strike pattern will be either classified as rearfoot strike or non-rearfoot strike. This is determined by video analysis of 240hz camera. All participants baseline foot strike pattern was rearfoot at study enrollment.
Immediately post-training, 6mo post-training, and 1yr post-training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury Incidence Between Foot Strike Patterns
Time Frame: 1yr
Percentage of runners that became injured over 1 yr. Injury defined as pain in the lower extremity that caused restriction or stoppage of running for at least one week, or required the runner to consult a physician or other health care professional.
1yr
Relative Risk of Injury
Time Frame: 1yr
Risk of runner to develop a knee injury based on foot-strike pattern
1yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jamie B Morris, DPT, Keller Army Community Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimated)

July 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 404239-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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