Video Telehealth Gait Retraining for Running-Related Knee Pain

Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With 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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Telemedicine; Running; Knee
• Intervention / Treatment: Procedure: Telehealth Gait Retraining; Procedure: Standard Physical Therapy Treatment; Procedure: Return to Running Protocol; Procedure: At Home Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Crowell, PT, DSc; Phone Number: 8459383067; Email: michael.s.crowell.mil@mail.mil

Study Locations

• United States
  • New York
    • West Point, New York, United States, 10966
      • Recruiting
      • Keller Army Community Hospital - Arvin Physical Therapy
      • Contact: Michael Crowell, PT, DSc; Phone Number: 845-938-3067; Email: michael.s.crowell.mil@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Keller Army Community Hospital
• Collaborators: Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 19KACH004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No