Clinical trial NCT03486405: A Randomized Control Trial: Returning to Run After Injury
Official title: A Randomized Control Trial: Returning to Run After Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
First posted: 2018-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be a randomized control trial crossover design.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Foot Strike Pattern
timeFrame: 6 months
Secondary outcomes:
measure: Perceived running pain
timeFrame: 6 months
measure: Perceived running effort
timeFrame: 6 months
measure: Perceived effort of running
timeFrame: 6 months
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital
state: New York
Study officials:
References: