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Completed

NCT Number: NCT04269473

Video Telehealth Gait Retraining for Running-Related Knee Pain

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.

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Key information

Conditions

Telemedicine Knee Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Running Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keller Army Community Hospital - Arvin Physical Therapy

West Point, New York, 10966, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth Gait Retraining

Procedure

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.

Standard Physical Therapy Treatment

Procedure

Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.

Return to Running Protocol

Procedure

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.

At Home Exercise Program

Procedure

The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Keller Army Community Hospital

Fed

Collaborators

  • Uniformed Services University of the Health Sciences

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2020
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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