Athletic InjuriesNCT03302975
Running Retraining to Minimize Braking Forces
A study testing Real-time visual biofeedback during treadmill running in people with Athletic Injuries, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Real-time visual biofeedback during treadmill running
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Gait Modification Training Program on Impact Loading and Running-related Injuries
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.
- Conditions
- Athletic Injuries
- Being tested
- Real-time visual biofeedback during treadmill running
- Keywords
- Running, Biomechanics, Kinetics
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time visual biofeedback during treadmill runningDevice
Real-time biofeedback of braking forces during running
| Study group | Role | What they receive |
|---|---|---|
| Real time biofeedback | Experimental | Real-time visual biofeedback of braking forces during a treadmill run. Receives: Device: Real-time visual biofeedback during treadmill running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Braking Force
The peak horizontal force applied in the posterior direction during the stance phase of running
Measured: 15 weeks
Secondary outcomes (2)
Average Vertical Loading Rate
The average vertical loading rate during stance phase
Measured: 15 weeks
Step Length
The average step length
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start2 Oct 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Fortius Sport & Health
- Responsible party
- Principal investigator, Michael Hunt, University of British Columbia
- Investigators
- Michael A Hunt, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302975
- Sponsor's protocol ID
- H16-00413
- Status last verified
- Jan 2020
- First submitted
- 2 Oct 2017
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Gait Modification Training Program on Impact Loading and Running-related Injuries
- ClinicalTrials.gov ID
- NCT03302975
- Acronym / sponsor ID
- H16-00413
- Conditions
- Athletic Injuries
- Keywords
- Running, Biomechanics, Kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Fortius Sport & Health
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real time biofeedback | Experimental | Device: Real-time visual biofeedback during treadmill runningReal-time visual biofeedback of braking forces during a treadmill run. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time visual biofeedback during treadmill runningReal-time biofeedback of braking forces during running | Device | Real time biofeedback |
Primary outcome
Peak Braking Force
Time frame: 15 weeks
The peak horizontal force applied in the posterior direction during the stance phase of running
2 secondary outcomes
Average Vertical Loading Rate
Time frame: 15 weeks
Step Length
Time frame: 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30526232Napier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Hunt, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time visual biofeedback during treadmill running in people with Athletic Injuries, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Braking Force (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.