A Randomized Control Trial: Returning to Run After Injury

NCT ID: NCT03486405

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2019-05-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: 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.

Interventions

Control group

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 Type: OTHER

Intervention group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Pain free walking 2 miles in 35 minutes

2. Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry

3. 20 unassisted single leg heel raises

4. Recovering from a lower-extremity injury

Exclusion Criteria

1. History of previous stress fracture / fracture of the foot

2. Participant who already uses a non-rearfoot strike running pattern

3. Participant is pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Keller Army Community Hospital

FED

Sponsor Role: lead

Responsible Party

Kyle East

Major, United States Air Force

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Keller Army Community Hospital

West Point, New York, United States

Countries

United States

Other Identifiers

KACH2018

Identifier Type: -

Identifier Source: org_study_id