Video Telehealth Gait Retraining for Running-Related Knee Pain

Overview

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.

Full Title of Study: “Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2022

Interventions

  • Procedure: Telehealth Gait Retraining
    • 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.
  • Procedure: Standard Physical Therapy Treatment
    • Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.
  • Procedure: Return to Running Protocol
    • 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.
  • Procedure: At Home Exercise Program
    • The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.

Arms, Groups and Cohorts

  • Experimental: Experimental Group
    • 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.
  • Active Comparator: Control Group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Worst knee pain during running assessed by Visual Analogue Scale (VAS)
    • Time Frame: Change from baseline to 10-weeks
    • 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.
  • Worst knee pain after running assessed by Visual Analogue Scale (VAS)
    • Time Frame: Change from baseline to 10-weeks
    • 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.
  • Foot strike pattern during running measured with motion capture
    • Time Frame: Change from baseline to 10-weeks
    • Portion of the foot that makes initial contact with the ground at the start of each stance phase during running.

Secondary Measures

  • University of Wisconsin Running Injury and Recovery Index
    • Time Frame: Change from baseline to 10-weeks and 14-weeks
    • 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.
  • Worst non-knee pain during running assessed by Visual Analogue Scale (VAS)
    • Time Frame: Change from baseline to 10-weeks and 14-weeks
    • 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.
  • Worst knee pain overall assessed by Visual Analogue Scale (VAS)
    • Time Frame: Change from baseline to 10-weeks and 14-weeks
    • 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.
  • Knee function assessed with the single assessment numeric evaluation method
    • Time Frame: Change from baseline to 10-weeks and 14-weeks
    • Participants will rate their knee function on a scale of 0 (least normal) to 100 (most normal).
  • Knee function assessed with the anterior knee pain scale
    • Time Frame: Change from baseline to 10-weeks and 14-weeks
    • 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).
  • Worst knee pain during running assessed by Visual Analogue Scale (VAS)
    • Time Frame: Change from baseline to 14-weeks
    • 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.
  • Worst knee pain after running assessed by Visual Analogue Scale (VAS)
    • Time Frame: Change from baseline to 14-weeks
    • 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.
  • Foot strike pattern during running measured with motion capture
    • Time Frame: Change from baseline to 14-weeks
    • Portion of the foot that makes initial contact with the ground at the start of each stance phase during running.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Keller Army Community Hospital
  • Collaborator
    • Uniformed Services University of the Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Michael Crowell, PT, DSc, 8459383067, michael.s.crowell.mil@mail.mil

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