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Completed

NCT Number: NCT03486405

A Randomized Control Trial: Returning to Run After Injury

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keller Army Community Hospital

West Point, New York, 10996, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

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 group

Other

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.

Primary outcomes

  1. Foot Strike Pattern

    Time frame: 6 months

    Analyzed through slow motion camera on an instrumented treadmill.

Secondary outcomes

  1. Perceived running pain

    Time frame: 6 months

    Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.

  2. 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.

  3. Perceived effort of running

    Time frame: 6 months

    Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.

Sponsors and collaborators

Lead sponsor

Keller Army Community Hospital

Fed

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2018
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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