Overuse InjurySTRIDeNCT04747223
Step Rate Retraining to Reduce Injury and Disability (STRIDe)
A study testing Run Gait Retraining in people with Overuse Injury and Lower Extremity Problem, run by Army-Baylor University Doctoral Program in Physical Therapy.
Trial summary
This study will be the first project to evaluate the effectiveness of wearable technology (Garmin Forerunner35) while performing gait retraining in field on military members. The watch will provide real time feedback to the runner on their step rate while performing running sessions outside of the lab. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overuse Injury, Lower Extremity Problem, Stress Injury, Repetitive
- What is being tested?
- Run Gait Retraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Active Duty, Department of Defense beneficiaries
- History of running-related overuse, musculoskeletal injury of the lower extremity (knee, hip, lower leg, or bone stress injury) within the last six months
- Currently able to run continuously for at least 15 minutes at self-selected pace, 3 times per week.
- 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 surgery in the previous 6 months
- Any lower extremity or low back exercise profile that limits running
- Participant has already completed a step rate, gait retraining program
- Participant has a step rate greater than 176 steps per minute
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Step Rate Retraining to Reduce Injury and Disability: A Randomized Controlled Trial
This study will be the first project to evaluate the effectiveness of wearable technology (Garmin Forerunner35) while performing gait retraining in field on military members. The watch will provide real time feedback to the runner on their step rate while performing running sessions outside of the lab. This allows the runner to modify their step rate to meet a recommended step rate provided by the study team member.
Aim 1: To demonstrate the utility of wearable sensors to modify running step rate through real time biofeedback.
Aim 2: To determine whether altering step rate using real time biofeedback reduces lower extremity musculoskeletal injury reoccurrence within 1 year post training.
Read the detailed description
Volunteers meeting all inclusion and exclusion criteria will read and sign an informed consent form approved by the institutional review board (IRB). After consenting, each participant will answer a demographic questionnaire related to injury history and pertinent injury risk factors (location, duration and type of previous injury, profile time, height, weight, changes in menstruation, etc). The participant will then undergo a running analysis in which the individual will run on an instrumented treadmill while video of running form in the sagittal plane and frontal plane are captured using two stationary two-dimensional digital cameras sampling at 240 Hz. The video will capture the runner from the waist down in order to protect privacy and blinding. Information collected from the treadmill will include AVLR of vGRF, while step rate and other kinematic information will be collected from video analysis. Volunteers will run at their self-selected pace for three minutes on a treadmill, with step rate and AVLR analyzed during the last minute of running. During the inital data collection, if the participant's step rate is greater than 176 spm, the participant will be exluded from the study at this time. The same data collection procedure will be repeated for all participants after retraining and for a subset of participants at 6 months to observe post intervention AVLR and step rate.
Volunteers will then be placed into a retraining group and a control group through random allocation. Each participant, regardless of group, will be provided a Garmin Forerunner35 to use while performing PRT with their unit and/or personal physical training for ten in-field training sessions. The ten in-field training sessions will be performed by the participant outside of the researcher's lab without a researcher present. The participant will be instructed to return to their normal running routine, but to use the watch during 10 running sessions to either monitor and modify their step rate for the retraining group or their pace and distance for the control group. Both groups will receive a training log to track their training sessions.
The retraining group will receive a watch accelerometer to use for monitoring their step rate with instructions to increase their preferred step rate by 7.5% over the ten in-field training sessions. The runner will receive a training log with a target step rate recorded on it. The target step rate will be a 7.5% increase from the preferred step rate the runner used during the gait analysis. The researcher will provide instruction to the participant to match the target step rate while the participants are performing their in-field training sessions by using the watch to monitor their step rate. The watch provides the runner with real-time feedback on their step rate. This allows the runner to monitor their step rate while running and the runner should either increase or decrease their step rate to meet the target step rate provided by the study team member. Training units at FT. Sam Houston perform ability group or self-paced runs for the majority of their endurance training, so participants should not have difficulty adjusting their step rates IAW study plans. Willy et al. was successful using eight in-field training sessions to sustain a 7.5% increase in step rate 1 month post-training in healthy runners (Willy 2016). Adherence to step rate will be assessed at the follow-up by reviewing the last 7 training sessions in the history of the watch. The watch only saves 7 sessions at a time to the watch memory without connecting to an internet database. Viewing the last 7 sessions allows the investigators to assess adherence without relying on the runner to upload data to a server before the participants have completed their training sessions. The average step rate from the last 7 training sessions will be input into an excel spreadsheet and the training sessions will be deleted from the watch.
The control group will receive the same device to monitor their pace but receive no instruction to change their preferred step rate. The participant will also receive a training log, but will track their pace and distance for each run.
Every participant will perform a 2-3 minute running session on the treadmill after data collection in order to acclimate looking down at the watch, periodically, for 3-5 seconds. This should minimize risk with falling while intermittently looking at the watch for feedback while running overground without supervision.
Volunteers will return after 10 in-field training sessions using their monitoring device and a subset of the study participants will return at 6 months to re-assess AVLR and step rate. The intake questionnaire asks if a participant will remain in the Fort Sam Houston area for 7 months after study enrollment. If the participant mark yes, investigators will ask them if the participant would return for a six month follow-up. Investigators will have 30 runners (15 from control group and 15 from retraining group) return for a six month follow-up.
The watch has GPS capability to provide accurate feedback on the runner's pace and distance. Investigators will not be monitoring GPS location information for the purpose of this study. All running data will be deleted off the watch when the participant return for their follow-up after the 10 in-field training sessions.
A retrospective medical record review, using AHLTA, querying lower extremity injury diagnoses and low back pain will be conducted at six months and at the completion of one year after the retraining program. All volunteers will also receive four email surveys over the year asking them to give their weekly running mileage and (yes/no) if the participant has limited activity due to a running-related overuse injury for one or more days during that quarter. If the answer is yes, the runner will receive additional questions regarding the location and nature of the injury. This quarterly survey is necessary to maximize the accuracy of mileage and injury information to account for mileage conducted and for injuries for which the runner does not seek medical attention. If after 4 weeks the email response rate is less than 50%, the subjects will be contacted by phone to respond to the survey questions. A retrospective profile review, using MODS/Eprofile, querying limited duty days from running-related injuries will be conducted at six months and at the completion of one year after the retraining program. The participants will be required to return the Garmin Watch at the completion of the retraining program or if the participant chooses to leave the study at any time.
- Conditions
- Overuse Injury, Lower Extremity Problem, Stress Injury, Repetitive, Patellofemoral Pain Syndrome, Shin Splint
- Being tested
- Run Gait Retraining
- Keywords
- Running-related lower extremity overuse injuries
- Medical subject headings
- Cumulative Trauma Disorders, Patellofemoral Pain Syndrome, Medial Tibial Stress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Run Gait RetrainingOther
Running step rate will be retrained by real-time biofeedback via a watch accelerometer. Recent literature showed that performing gait retraining by altering step rate reduces loading rates and joint stress that are associated with lower extremity injuries (Wilson et al 2014, Lenhart et al 2014, Heidersheit et al 2011).
| Study group | Role | What they receive |
|---|---|---|
| Retraining (RT) Group | Experimental | The retraining group will receive a watch accelerometer to use for monitoring their step rate with instructions to increase their preferred step rate by 7.5% over the ten in-field training sessions. Receives: Other: Run Gait Retraining |
| Control (CON) Group | No intervention | The control group will receive the same device to monitor their pace but receive no instruction to change their preferred step rate over the ten in-field training sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average vertical loading rate (AVLR)
The slope of the line on a ground reaction force curve from initial contact to the impact peak
Measured: Baseline, 10 weeks, 6 months
Change in Step rate (SR)
The number of steps a participant takes per minute of running
Measured: Baseline, 10 weeks, 6 months
Injury
The number of lower extremity, over-use injuries sustained within 1 year after completing the ten in-field training sessions
Measured: 1 year
Secondary outcomes (2)
Absolute risk reduction
Change in risk for lower extremity, over-use injuries in those that complete step rate retraining
Measured: 1 year
Limited duty days
Number of days a soldier is non-deployable due to a lower extremity, over-use injury
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overuse InjuryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army-Baylor University Doctoral Program in Physical Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747223
- Sponsor's protocol ID
- C.2020.058d
- Acronym
- STRIDe
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heiderscheit BC, Chumanov ES, Michalski MP, Wille CM, Ryan MB. Effects of step rate manipulation on joint mechanics during running. Med Sci Sports Exerc. 2011 Feb;43(2):296-302. doi: 10.1249/MSS.0b013e3181ebedf4.
PubMed 20581720Willson JD, Ratcliff OM, Meardon SA, Willy RW. Influence of step length and landing pattern on patellofemoral joint kinetics during running. Scand J Med Sci Sports. 2015 Dec;25(6):736-43. doi: 10.1111/sms.12383. Epub 2015 Jan 14.
PubMed 25585589Lenhart R, Thelen D, Heiderscheit B. Hip muscle loads during running at various step rates. J Orthop Sports Phys Ther. 2014 Oct;44(10):766-74, A1-4. doi: 10.2519/jospt.2014.5575. Epub 2014 Aug 25.
PubMed 25156044Willy RW, Buchenic L, Rogacki K, Ackerman J, Schmidt A, Willson JD. In-field gait retraining and mobile monitoring to address running biomechanics associated with tibial stress fracture. Scand J Med Sci Sports. 2016 Feb;26(2):197-205. doi: 10.1111/sms.12413. Epub 2015 Feb 4.
PubMed 25652871
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Rate Retraining to Reduce Injury and Disability: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04747223
- Acronym / sponsor ID
- STRIDe / C.2020.058d
- Conditions
- Overuse Injury, Lower Extremity Problem, Stress Injury, Repetitive, Patellofemoral Pain Syndrome, Shin Splint
- Keywords
- Running-related lower extremity overuse injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Army-Baylor University Doctoral Program in Physical TherapyUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be the first project to evaluate the effectiveness of wearable technology (Garmin Forerunner35) while performing gait retraining in field on military members. The watch will provide real time feedback to the runner on their step rate while performing running sessions outside of the lab. This allows the runner to modify their step rate to meet a recommended step rate provided by the study team member.
Aim 1: To demonstrate the utility of wearable sensors to modify running step rate through real time biofeedback.
Aim 2: To determine whether altering step rate using real time biofeedback reduces lower extremity musculoskeletal injury reoccurrence within 1 year post training.
Detailed description
Volunteers meeting all inclusion and exclusion criteria will read and sign an informed consent form approved by the institutional review board (IRB). After consenting, each participant will answer a demographic questionnaire related to injury history and pertinent injury risk factors (location, duration and type of previous injury, profile time, height, weight, changes in menstruation, etc). The participant will then undergo a running analysis in which the individual will run on an instrumented treadmill while video of running form in the sagittal plane and frontal plane are captured using two stationary two-dimensional digital cameras sampling at 240 Hz. The video will capture the runner from the waist down in order to protect privacy and blinding. Information collected from the treadmill will include AVLR of vGRF, while step rate and other kinematic information will be collected from video analysis. Volunteers will run at their self-selected pace for three minutes on a treadmill, with step rate and AVLR analyzed during the last minute of running. During the inital data collection, if the participant's step rate is greater than 176 spm, the participant will be exluded from the study at this time. The same data collection procedure will be repeated for all participants after retraining and for a subset of participants at 6 months to observe post intervention AVLR and step rate.
Volunteers will then be placed into a retraining group and a control group through random allocation. Each participant, regardless of group, will be provided a Garmin Forerunner35 to use while performing PRT with their unit and/or personal physical training for ten in-field training sessions. The ten in-field training sessions will be performed by the participant outside of the researcher's lab without a researcher present. The participant will be instructed to return to their normal running routine, but to use the watch during 10 running sessions to either monitor and modify their step rate for the retraining group or their pace and distance for the control group. Both groups will receive a training log to track their training sessions.
The retraining group will receive a watch accelerometer to use for monitoring their step rate with instructions to increase their preferred step rate by 7.5% over the ten in-field training sessions. The runner will receive a training log with a target step rate recorded on it. The target step rate will be a 7.5% increase from the preferred step rate the runner used during the gait analysis. The researcher will provide instruction to the participant to match the target step rate while the participants are performing their in-field training sessions by using the watch to monitor their step rate. The watch provides the runner with real-time feedback on their step rate. This allows the runner to monitor their step rate while running and the runner should either increase or decrease their step rate to meet the target step rate provided by the study team member. Training units at FT. Sam Houston perform ability group or self-paced runs for the majority of their endurance training, so participants should not have difficulty adjusting their step rates IAW study plans. Willy et al. was successful using eight in-field training sessions to sustain a 7.5% increase in step rate 1 month post-training in healthy runners (Willy 2016). Adherence to step rate will be assessed at the follow-up by reviewing the last 7 training sessions in the history of the watch. The watch only saves 7 sessions at a time to the watch memory without connecting to an internet database. Viewing the last 7 sessions allows the investigators to assess adherence without relying on the runner to upload data to a server before the participants have completed their training sessions. The average step rate from the last 7 training sessions will be input into an excel spreadsheet and the training sessions will be deleted from the watch.
The control group will receive the same device to monitor their pace but receive no instruction to change their preferred step rate. The participant will also receive a training log, but will track their pace and distance for each run.
Every participant will perform a 2-3 minute running session on the treadmill after data collection in order to acclimate looking down at the watch, periodically, for 3-5 seconds. This should minimize risk with falling while intermittently looking at the watch for feedback while running overground without supervision.
Volunteers will return after 10 in-field training sessions using their monitoring device and a subset of the study participants will return at 6 months to re-assess AVLR and step rate. The intake questionnaire asks if a participant will remain in the Fort Sam Houston area for 7 months after study enrollment. If the participant mark yes, investigators will ask them if the participant would return for a six month follow-up. Investigators will have 30 runners (15 from control group and 15 from retraining group) return for a six month follow-up.
The watch has GPS capability to provide accurate feedback on the runner's pace and distance. Investigators will not be monitoring GPS location information for the purpose of this study. All running data will be deleted off the watch when the participant return for their follow-up after the 10 in-field training sessions.
A retrospective medical record review, using AHLTA, querying lower extremity injury diagnoses and low back pain will be conducted at six months and at the completion of one year after the retraining program. All volunteers will also receive four email surveys over the year asking them to give their weekly running mileage and (yes/no) if the participant has limited activity due to a running-related overuse injury for one or more days during that quarter. If the answer is yes, the runner will receive additional questions regarding the location and nature of the injury. This quarterly survey is necessary to maximize the accuracy of mileage and injury information to account for mileage conducted and for injuries for which the runner does not seek medical attention. If after 4 weeks the email response rate is less than 50%, the subjects will be contacted by phone to respond to the survey questions. A retrospective profile review, using MODS/Eprofile, querying limited duty days from running-related injuries will be conducted at six months and at the completion of one year after the retraining program. The participants will be required to return the Garmin Watch at the completion of the retraining program or if the participant chooses to leave the study at any time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retraining (RT) Group | Experimental | Other: Run Gait RetrainingThe retraining group will receive a watch accelerometer to use for monitoring their step rate with instructions to increase their preferred step rate by 7.5% over the ten in-field training sessions. |
| Control (CON) Group | No intervention | –The control group will receive the same device to monitor their pace but receive no instruction to change their preferred step rate over the ten in-field training sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the age of 18 - 50 years
- Active Duty, Department of Defense beneficiaries
- History of running-related overuse, musculoskeletal injury of the lower extremity (knee, hip, lower leg, or bone stress injury) within the last six months
- Currently able to run continuously for at least 15 minutes at self-selected pace, 3 times per week.
- Read and speak English well enough to provide informed consent and follow study instructions
Key exclusion criteria (5 listed)
- Known pregnancy currently or in the previous 6 months
- Lower extremity or low back surgery in the previous 6 months
- Any lower extremity or low back exercise profile that limits running
- Participant has already completed a step rate, gait retraining program
- Participant has a step rate greater than 176 steps per minute
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 |
|---|---|---|
| Run Gait RetrainingRunning step rate will be retrained by real-time biofeedback via a watch accelerometer. Recent literature showed that performing gait retraining by altering step rate reduces loading rates and joint stress that are associated with lower extremity injuries (Wilson et al 2014, Lenhart et al 2014, Heidersheit et al 2011). | Other | Retraining (RT) Group |
Primary outcome
Change in Average vertical loading rate (AVLR)
Time frame: Baseline, 10 weeks, 6 months
The slope of the line on a ground reaction force curve from initial contact to the impact peak
Change in Step rate (SR)
Time frame: Baseline, 10 weeks, 6 months
The number of steps a participant takes per minute of running
Injury
Time frame: 1 year
The number of lower extremity, over-use injuries sustained within 1 year after completing the ten in-field training sessions
2 secondary outcomes
Absolute risk reduction
Time frame: 1 year
Limited duty days
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 20581720Heiderscheit BC, Chumanov ES, Michalski MP, Wille CM, Ryan MB. Effects of step rate manipulation on joint mechanics during running. Med Sci Sports Exerc. 2011 Feb;43(2):296-302. doi: 10.1249/MSS.0b013e3181ebedf4.
- Background: PubMed 25585589Willson JD, Ratcliff OM, Meardon SA, Willy RW. Influence of step length and landing pattern on patellofemoral joint kinetics during running. Scand J Med Sci Sports. 2015 Dec;25(6):736-43. doi: 10.1111/sms.12383. Epub 2015 Jan 14.
- Background: PubMed 25156044Lenhart R, Thelen D, Heiderscheit B. Hip muscle loads during running at various step rates. J Orthop Sports Phys Ther. 2014 Oct;44(10):766-74, A1-4. doi: 10.2519/jospt.2014.5575. Epub 2014 Aug 25.
- Background: PubMed 25652871Willy RW, Buchenic L, Rogacki K, Ackerman J, Schmidt A, Willson JD. In-field gait retraining and mobile monitoring to address running biomechanics associated with tibial stress fracture. Scand J Med Sci Sports. 2016 Feb;26(2):197-205. doi: 10.1111/sms.12413. Epub 2015 Feb 4.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Run Gait Retraining in people with Overuse Injury and Lower Extremity Problem, run by Army-Baylor University Doctoral Program in Physical Therapy.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Morris, DPT, DSc (7069739040, jamiebushmorris@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average vertical loading rate (AVLR) (time frame: Baseline, 10 weeks, 6 months). The study lists 3 primary outcomes in all. 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 NCT04747223, which also lists 4 linked publications.
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 10 Feb 2021.