Clinical trial NCT04269473: Video Telehealth Gait Retraining for Running-Related Knee Pain
Official title: Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Running
Knee
Pain
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2020-02-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this randomized control trial, participants with running-related knee pain will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a telehealth gait retraining intervention, an at-home exercise program, a return to running protocol, and standard physical therapy. Participants in the control group will receive an at-home exercise program, a return to running protocol, and standard physical therapy. Data will be collected before intervention, at 10-weeks, and at 14-weeks to determine efficacy of the intervention.


Eligibility criteria: Inclusion Criteria:

* Active Duty Soldier or Cadet between the ages of 18 to 60 years old
* Knee pain that occurs during and/or after running that was not due to a recent acute trauma (such as an accident or a fall) and that is a pain intensity of at least a '3' and no greater than a '7' on a numeric pain rating scale with '0' meaning "no pain" and '10' meaning the "worst possible pain"
* Fluent in speaking and reading English

Exclusion Criteria:

* Currently on an Army running limiting profile for something other than knee pain
* Presence of rheumatoid or neurological diseases
* Plans to deploy or permanent change of station (PCS) within 4 months
* Current lower extremity injury other than knee pain
* History of traumatic knee injury (such as a surgery, ligament tear, or meniscal tear)
* Current pregnancy
* Inability to perform 20 unassisted single leg heel raises on each leg
* A non-rearfoot strike pattern during running
* Showing signs of ligamentous instability, meniscus pathology, or knee effusion

Primary outcomes:
measure: Worst knee pain during running assessed by Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 10-weeks
measure: Worst knee pain after running assessed by Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 10-weeks
measure: Foot strike pattern during running measured with motion capture
timeFrame: Change from baseline to 10-weeks
Secondary outcomes:
measure: University of Wisconsin Running Injury and Recovery Index
timeFrame: Change from baseline to 10-weeks and 14-weeks
measure: Worst non-knee pain during running assessed by Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 10-weeks and 14-weeks
measure: Worst knee pain overall assessed by Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 10-weeks and 14-weeks
measure: Knee function assessed with the single assessment numeric evaluation method
timeFrame: Change from baseline to 10-weeks and 14-weeks
measure: Knee function assessed with the anterior knee pain scale
timeFrame: Change from baseline to 10-weeks and 14-weeks
measure: Worst knee pain during running assessed by Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 14-weeks
measure: Worst knee pain after running assessed by Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 14-weeks
measure: Foot strike pattern during running measured with motion capture
timeFrame: Change from baseline to 14-weeks
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital - Arvin Physical Therapy
state: New York
Study officials:
References: