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CompletedNCT03302975Updated Jan 18, 2020Results posted

Running Retraining to Minimize Braking Forces

An interventional study of Real-time visual biofeedback during treadmill running in Athletic Injuries, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Athletic Injuries

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Keywords

  • Running
  • Biomechanics
  • Kinetics
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Real time biofeedback

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

    Device: Real-time visual biofeedback during treadmill running

Interventions

  • DeviceReal-time visual biofeedback during treadmill running

    Real-time biofeedback of braking forces during running

05

What researchers measure

Primary outcomes

  1. Peak Braking Force

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

    Time frame: 15 weeks

Secondary outcomes

  1. Average Vertical Loading Rate

    The average vertical loading rate during stance phase

    Time frame: 15 weeks

  2. Step Length

    The average step length

    Time frame: 15 weeks

06

Results

Posted Jan 18, 2020

Participant flow

Participant flow — Overall Study
MilestoneReal Time Biofeedback
Started16
Completed12
Not completed4
Withdrew: Lost to follow-up4

Outcome measures

PrimaryPeak Braking Force

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

Time frame:
15 weeks
Reported as:
Mean · Body Weight
Peak Braking Force
Body WeightReal Time Biofeedback
Peak Braking Force0.24 ± 0.02
Statistical analysis
  • Real Time Biofeedback · ANOVA · p = 0.001
SecondaryAverage Vertical Loading Rate

The average vertical loading rate during stance phase

Time frame:
15 weeks
Reported as:
Mean · Body Weight/second
Average Vertical Loading Rate
Body Weight/secondReal Time Biofeedback
Average Vertical Loading Rate36.05 ± 7.5
SecondaryStep Length

The average step length

Time frame:
15 weeks
Reported as:
Mean · m
Step Length
mReal Time Biofeedback
Step Length0.85 ± 0.05

Adverse events

Collected over Adverse event data were collected over a 15-week period over the course of the running training program.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Real Time Biofeedback0/12 (0%)0/12 (0%)0/12 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Real Time Biofeedback
<=18 years0
Between 18 and 65 years12
>=65 years0
Age, Continuous
Age, Continuous(years)Real Time Biofeedback
Mean39.2 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Real Time Biofeedback
Female12
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Real Time Biofeedback
Region of Enrollment
Region of Enrollment(participants)Real Time Biofeedback
Canada12
Peak Braking Force
Peak Braking Force(Body Weight)Real Time Biofeedback
Mean0.28 ± 0.04
Step Length
Step Length(m)Real Time Biofeedback
Mean0.91 ± 0.07
07

Study locations

1 site
  • Fortius Sport & Health
    Burnaby, British Columbia V5B 0A7, Canada
08

References and documents

Publications

  • 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. PubMed 30526232 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 10, 2016

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03302975
Lead sponsor
University of British Columbia
Collaborators
Fortius Sport & Health
Responsible party
Michael Hunt (Associate Professor, University of British Columbia) — Principal investigator
First posted
Oct 5, 2017
Start date
Oct 2, 2017
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018
Results posted
Jan 18, 2020
Last update
Jan 18, 2020

Study contacts

Michael A Hunt, PhD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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