Knee InjuriesNCT03486405
A Randomized Control Trial: Returning to Run After Injury
A study testing Intervention group in people with Knee Injuries, run by Keller Army Community Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of telehealth via video feedback to transition rear foot strike runners to non-heel strike runner following a lower extremity injury. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to 15 May 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain free walking 2 miles in 35 minutes
- Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry
- 20 unassisted single leg heel raises
- Recovering from a lower-extremity injury
Who cannot join
- History of previous stress fracture / fracture of the foot
- Participant who already uses a non-rearfoot strike running pattern
- Participant is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital
West Point, New York, 10996
About this study
The purpose of this study is to examine the effectiveness of telehealth via video feedback to transition rear foot strike runners to non-heel strike runner following a lower extremity injury. Telehealth re-education gait training is much cheaper than in-clinic retraining sessions with a medical provider and could be much more widely used by both consumers and researchers as a training aid, a way to help alter running form, prevent running injuries and be used as a tool for use in the rehabilitation of running related injuries.
Read the detailed description
A convenience sample of 30 runners from the United States Military Academy (USMA) at West Point, New York (NY) who are recovering from a lower-extremity injury and are interested in participating in a return to run program. Acceptable lower-extremity injuries can include stress fractures proximal to the ankle, anterior chronic exertional compartment syndrome (CECS), patella-femoral pain syndrome, osteoarthritis of the lower-extremity, iliotibial band syndrome, chronic lower-extremity pain and or any participant that may benefit from the following; shorter stride, increased step rate, reduced knee loading, and reduced ground reaction force average vertical loading rates (AVLR). All participants will be screened via questionnaire and physical assessment for inclusion / exclusion from the study. Upon enrollment runners will be randomized into two groups. Regardless of group, all runners will have their running form and foot strike pattern analyzed using an instrumented treadmill and high-speed motion capture initially and at week 10. Kinetic and kinematic data including AVLR, impulse, foot strike pattern (FSP), contact time, step length, and step rate will be recorded at these time points. Additionally, all runners will receive the same graduated return to run intervals and 4-week home exercise program. Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.
- Conditions
- Knee Injuries
- Being tested
- Control group, Intervention group
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Control group runners will receive the same graduated return to run intervals and 4-week home exercise program. However, they will receive no video education during the initial 10 weeks.
Intervention groupOther
Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental group will have no in person education by researchers. All education and running modification will be performed via video. Education on running form, a home exercise program, and a 4 week return to run program will be provided to the subjects through e-mail. They will also receive the same in person video analysis performed at weeks 0 (initial), 10 and 6 months to assess running kinematics. Receives: Other: Intervention group |
| Control group | Active comparator | This group will have the same 4 week return to run program, home exercise program, and video analysis performed at weeks 0 (initial), 10 and 6 months to assess running kinematics. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Strike Pattern
Analyzed through slow motion camera on an instrumented treadmill.
Measured: 6 months
Secondary outcomes (3)
Perceived running pain
Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.
Measured: 6 months
Perceived running effort
Subjects will self evaluate running ease and efficiency through the University of Wisconsin Running Injury and Recovery Index.
Measured: 6 months
Perceived effort of running
Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start4 Oct 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be a randomized control trial crossover design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Kyle East, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486405
- Sponsor's protocol ID
- KACH2018
- Status last verified
- May 2019
- First submitted
- 7 Feb 2018
- Last updated
- 20 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The principal investigator will keep your research records. These records may be looked at by staff from the Keller Army Community Hospital Department of Clinical Investigation, the Keller Army Community Hospital (KACH) Institutional Review Board (IRB), the Army Clinical Investigation Regulatory Office (CIRO), the Department of Defense (DoD) Higher Level Review, and other government agencies as part of their duties. These duties include making sure that the research participants are protected. Your research records may be disclosed outside of the hospital, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to authorized research study personnel. This research study meets the confidentiality requirements of the Health Insurance Portability and Accountability Act (HIPAA).
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial: Returning to Run After Injury
- ClinicalTrials.gov ID
- NCT03486405
- Acronym / sponsor ID
- KACH2018
- Conditions
- Knee Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 3 Apr 2018 (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.
The purpose of this study is to examine the effectiveness of telehealth via video feedback to transition rear foot strike runners to non-heel strike runner following a lower extremity injury. Telehealth re-education gait training is much cheaper than in-clinic retraining sessions with a medical provider and could be much more widely used by both consumers and researchers as a training aid, a way to help alter running form, prevent running injuries and be used as a tool for use in the rehabilitation of running related injuries.
Detailed description
A convenience sample of 30 runners from the United States Military Academy (USMA) at West Point, New York (NY) who are recovering from a lower-extremity injury and are interested in participating in a return to run program. Acceptable lower-extremity injuries can include stress fractures proximal to the ankle, anterior chronic exertional compartment syndrome (CECS), patella-femoral pain syndrome, osteoarthritis of the lower-extremity, iliotibial band syndrome, chronic lower-extremity pain and or any participant that may benefit from the following; shorter stride, increased step rate, reduced knee loading, and reduced ground reaction force average vertical loading rates (AVLR). All participants will be screened via questionnaire and physical assessment for inclusion / exclusion from the study. Upon enrollment runners will be randomized into two groups. Regardless of group, all runners will have their running form and foot strike pattern analyzed using an instrumented treadmill and high-speed motion capture initially and at week 10. Kinetic and kinematic data including AVLR, impulse, foot strike pattern (FSP), contact time, step length, and step rate will be recorded at these time points. Additionally, all runners will receive the same graduated return to run intervals and 4-week home exercise program. Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a randomized control trial crossover design.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupThe experimental group will have no in person education by researchers. All education and running modification will be performed via video. Education on running form, a home exercise program, and a 4 week return to run program will be provided to the subjects through e-mail. They will also receive the same in person video analysis performed at weeks 0 (initial), 10 and 6 months to assess running kinematics. |
| Control group | Active comparator | Other: Control groupThis group will have the same 4 week return to run program, home exercise program, and video analysis performed at weeks 0 (initial), 10 and 6 months to assess running kinematics. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pain free walking 2 miles in 35 minutes
- Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry
- 20 unassisted single leg heel raises
- Recovering from a lower-extremity injury
Key exclusion criteria (3 listed)
- History of previous stress fracture / fracture of the foot
- Participant who already uses a non-rearfoot strike running pattern
- Participant is pregnant
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 |
|---|---|---|
| Control groupControl group runners will receive the same graduated return to run intervals and 4-week home exercise program. However, they will receive no video education during the initial 10 weeks. | Other | Control group |
| Intervention groupRunners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed. | Other | Intervention group |
Primary outcome
Foot Strike Pattern
Time frame: 6 months
Analyzed through slow motion camera on an instrumented treadmill.
3 secondary outcomes
Perceived running pain
Time frame: 6 months
Perceived running effort
Time frame: 6 months
Perceived effort of running
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: No. The principal investigator will keep your research records. These records may be looked at by staff from the Keller Army Community Hospital Department of Clinical Investigation, the Keller Army Community Hospital (KACH) Institutional Review Board (IRB), the Army Clinical Investigation Regulatory Office (CIRO), the Department of Defense (DoD) Higher Level Review, and other government agencies as part of their duties. These duties include making sure that the research participants are protected. Your research records may be disclosed outside of the hospital, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to authorized research study personnel. This research study meets the confidentiality requirements of the Health Insurance Portability and Accountability Act (HIPAA).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Knee Injuries, run by Keller Army Community Hospital at 1 site in United States.
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 3 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 20 May 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Foot Strike Pattern (time frame: 6 months). 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 20 May 2019.