A Randomized Control Trial: Returning to Run After Injury

Knee Injuries Clinical Trial

Official title:

A Randomized Control Trial: Returning to Run After Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486405
• Other study ID #: KACH2018
• Status: Completed
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2019
• Source: Keller Army Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Wounds and Injuries

Intervention

Other:
• 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 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.

Locations

Country	Name	City	State
United States	Keller Army Community Hospital	West Point	New York

Sponsors (1)

Lead Sponsor	Collaborator
Keller Army Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot Strike Pattern	Analyzed through slow motion camera on an instrumented treadmill.	6 months
Secondary	Perceived running pain	Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.	6 months
Secondary	Perceived running effort	Subjects will self evaluate running ease and efficiency through the University of Wisconsin Running Injury and Recovery Index.	6 months
Secondary	Perceived effort of running	Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.	6 months