NCT02495792

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable healthy

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

May 25, 2015

Results QC Date

September 11, 2017

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Foot Strike Pattern From Baseline

    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 Outcomes (2)

  • Injury Incidence Between Foot Strike Patterns

    1yr

  • Relative Risk of Injury

    1yr

Study Arms (2)

Control group

NO INTERVENTION

Group does not receive the biofeedback sensor

Biofeedback group

EXPERIMENTAL

Group does receive the biofeedback sensor

Device: Biofeedback Sensor

Interventions

Tibia accelerometer strapped to distal tibia to detect tibial shock

Biofeedback 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
MAJ Jamie Morris
Organization
Brooke Army Medical Center

Study Officials

  • Jamie B Morris, DPT

    Keller Army Community Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapy Sports Medicine Fellow

Study Record Dates

First Submitted

May 25, 2015

First Posted

July 13, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 2, 2024

Results First Posted

April 2, 2024

Record last verified: 2024-03