- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03486405
A Randomized Control Trial: Returning to Run After Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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West Point, New York, United States, 10996
- Keller Army Community Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of previous stress fracture / fracture of the foot
- Participant who already uses a non-rearfoot strike running pattern
- Participant is pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
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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.
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Active Comparator: Control group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Strike Pattern
Time Frame: 6 months
|
Analyzed through slow motion camera on an instrumented treadmill.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived running pain
Time Frame: 6 months
|
Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.
|
6 months
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Perceived running effort
Time Frame: 6 months
|
Subjects will self evaluate running ease and efficiency through the University of Wisconsin Running Injury and Recovery Index.
|
6 months
|
Perceived effort of running
Time Frame: 6 months
|
Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KACH2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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