Video Telehealth Gait Retraining for Running-Related Knee Pain

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain

Conditions
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Telemedicine, Running, Knee, Pain

Intervention / Treatment
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* Procedure: Telehealth Gait Retraining
* Procedure: Standard Physical Therapy Treatment
* Procedure: Return to Running Protocol
* Procedure: At Home Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Participants in the experimental group will receive a telehealth gait retraining intervention in addition to standard physical therapy rehabilitation for running-related knee pain, which includes: an at-home exercise program, a return to running protocol, and standard physical therapy evaluations. | Procedure: Telehealth Gait Retraining<br>* Telehealth gait retraining is a novel approach to train participants to adopt a non-rearfoot foot strike pattern during running via telecommunications. During telehealth gait retraining, video of a participant's running form are sent to clinicians over a mobile device app and running form feedback is given. This process is repeated once a week for four weeks and then every other week until week 8.<br>Procedure: Standard Physical Therapy Treatment<br>* Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.<br>Procedure: Return to Running Protocol<br>* The Return to Running protocol is a six-phase running volume progression to re-introduce running slowly and safely after experiencing a running-related injury.<br>Procedure: At Home Exercise Program<br>* The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.<br>|
| Active Comparator: Control Group<br>Participants in the control group will receive standard physical therapy rehabilitation for running-related knee pain, which includes: an at-home exercise program, a return to running protocol, and standard physical therapy evaluations. | Procedure: Standard Physical Therapy Treatment<br>* Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.<br>Procedure: Return to Running Protocol<br>* The Return to Running protocol is a six-phase running volume progression to re-introduce running slowly and safely after experiencing a running-related injury.<br>Procedure: At Home Exercise Program<br>* The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks | 
| Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks | 
| Foot strike pattern during running measured with motion capture | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. | Change from baseline to 10-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of Wisconsin Running Injury and Recovery Index | A 9-item questionnaire (range 0-36, higher scores indicate more function) that measures a runners assessment of running ability after sustaining a running-related injury. | Change from baseline to 10-weeks and 14-weeks | 
| Worst non-knee pain during running assessed by Visual Analogue Scale (VAS) | Worst pain intensity in a region other than the knee during running in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks and 14-weeks | 
| Worst knee pain overall assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity experienced overall in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks and 14-weeks | 
| Knee function assessed with the single assessment numeric evaluation method | Participants will rate their knee function on a scale of 0 (least normal) to 100 (most normal). | Change from baseline to 10-weeks and 14-weeks | 
| Knee function assessed with the anterior knee pain scale | Participants will rate their level of pain, disability, and impairment associated with their knee injury using a 13-item questionnaire (range 0-100, higher scores indicate better function). | Change from baseline to 10-weeks and 14-weeks | 
| Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 14-weeks | 
| Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 14-weeks | 
| Foot strike pattern during running measured with motion capture | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. | Change from baseline to 14-weeks |