- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495792
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
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:
- Between the age of 18 - 50 years
- Run on average 12mi per week
- DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment
- Read and speak English well enough to provide informed consent and follow study instructions
Exclusion Criteria:
- Known pregnancy currently or in the previous 6 months
- Lower extremity or low back pain in the previous 3 months
- Lower extremity or low back surgery in the previous 6 months
- Any lower extremity or low back exercise limiting profile
- Previous stress fracture of the foot
- 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.
Sponsor
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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