NCT03302975

Brief Summary

The proposed research study aims to investigate whether a gait modification training program to decrease peak braking forces during the stance phase of running will result in a reduction in impact loading and the incidence of running-related injuries among recreational distance runners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 2, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

October 2, 2017

Results QC Date

December 18, 2019

Last Update Submit

January 7, 2020

Conditions

Athletic Injuries

Keywords

RunningBiomechanicsKinetics

Outcome Measures

Primary Outcomes (1)

  • Peak Braking Force

    The peak horizontal force applied in the posterior direction during the stance phase of running

    15 weeks

Secondary Outcomes (2)

  • Average Vertical Loading Rate

    15 weeks

  • Step Length

    15 weeks

Study Arms (1)

Real time biofeedback

EXPERIMENTAL

Real-time visual biofeedback of braking forces during a treadmill run.

Device: Real-time visual biofeedback during treadmill running

Interventions

Real-time visual biofeedback during treadmill runningDEVICE

Real-time biofeedback of braking forces during running

Real time biofeedback

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to commit to a 15-week half-marathon training program
  • Have been running for at least 3 months prior to study commencement
  • Have participated in 2 or less half-marathons previously
  • Ability to run on a treadmill unaided
  • Ability to travel to testing facility for running analysis pre- and post-training program as well as for gait retraining sessions
  • Ability to understand written and spoken English
  • Meet the screening requirements (display less than -0.27BW mean peak braking force at baseline/screening assessment)

You may not qualify if:

  • Any lower extremity pathology in the previous 3 months or currently have pain in their lower back or lower extremities while running
  • Have undergone hip, knee, or ankle joint surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortius Sport & Health

Burnaby, British Columbia, V5B 0A7, Canada

Location

Related Publications (1)

  • Napier C, MacLean CL, Maurer J, Taunton JE, Hunt MA. Real-Time Biofeedback of Performance to Reduce Braking Forces Associated With Running-Related Injury: An Exploratory Study. J Orthop Sports Phys Ther. 2019 Mar;49(3):136-144. doi: 10.2519/jospt.2019.8587. Epub 2018 Dec 7.

    PMID: 30526232DERIVED

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Chris Napier
Organization
Univeristy of British Columbia
chris.napier@ubc.ca
604-721-1310

Study Officials

  • Michael A Hunt, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

October 2, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

January 18, 2020

Results First Posted

January 18, 2020

Record last verified: 2020-01

Locations

CA(1)