A Randomized Control Trial: Returning to Run After Injury
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedMay 20, 2019
May 1, 2019
7 months
February 7, 2018
May 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Foot Strike Pattern
Analyzed through slow motion camera on an instrumented treadmill.
6 months
Secondary Outcomes (3)
Perceived running pain
6 months
Perceived running effort
6 months
Perceived effort of running
6 months
Study Arms (2)
Intervention group
EXPERIMENTALThe 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 COMPARATORThis 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Pain free walking 2 miles in 35 minutes
- Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry
- unassisted single leg heel raises
- Recovering from a lower-extremity injury
You may not qualify if:
- History of previous stress fracture / fracture of the foot
- Participant who already uses a non-rearfoot strike running pattern
- Participant is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Keller Army Community Hospital
West Point, New York, 10996, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Major, United States Air Force
Study Record Dates
First Submitted
February 7, 2018
First Posted
April 3, 2018
Study Start
October 4, 2018
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
May 20, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
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).