HealthyNCT02495792
Using Real Time Biofeedback to Alter Running Mechanics
A study testing Biofeedback Sensor in people with Healthy, run by Keller Army Community Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Biofeedback Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Biofeedback Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback SensorDevice
Tibia accelerometer strapped to distal tibia to detect tibial shock
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Group does not receive the biofeedback sensor |
| Biofeedback group | Experimental | Group does receive the biofeedback sensor Receives: Device: Biofeedback Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-training, 6mo post-training, and 1yr post-training
Secondary outcomes (2)
Injury Incidence Between Foot Strike Patterns
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.
Measured: 1yr
Relative Risk of Injury
Risk of runner to develop a knee injury based on foot-strike pattern
Measured: 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionMay 2016
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.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jamie Morris, Keller Army Community Hospital
- Investigators
- Jamie B Morris, DPT, Principal investigator, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495792
- Sponsor's protocol ID
- 404239-2
- Status last verified
- Mar 2024
- First submitted
- 25 May 2015
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Real Time Biofeedback to Alter Running Biomechanics
- ClinicalTrials.gov ID
- NCT02495792
- Acronym / sponsor ID
- 404239-2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Group does not receive the biofeedback sensor |
| Biofeedback group | Experimental | Device: Biofeedback SensorGroup does receive the biofeedback sensor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Biofeedback SensorTibia accelerometer strapped to distal tibia to detect tibial shock | Device | Biofeedback group |
Primary outcome
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.
2 secondary outcomes
Injury Incidence Between Foot Strike Patterns
Time frame: 1yr
Relative Risk of Injury
Time frame: 1yr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jamie B Morris, DPT principal investigator
Keller Army Community Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Sensor in people with Healthy, run by Keller Army Community Hospital.
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 4 inclusion and 6 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 Apr 2024). 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?
Change in Foot Strike Pattern From Baseline (time frame: Immediately post-training, 6mo post-training, and 1yr post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.