Video Telehealth Gait Retraining for Running-Related Knee Pain

NCT04269473 | Completed

• 2 other identifiers: RHC-A-19-03519KACH004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemedicine; Running; Knee; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• University of Wisconsin Running Injury and Recovery Index

  Change from baseline to 10-weeks and 14-weeks

• Worst non-knee pain during running assessed by Visual Analogue Scale (VAS)

  Change from baseline to 10-weeks and 14-weeks

• Worst knee pain overall assessed by Visual Analogue Scale (VAS)

  Change from baseline to 10-weeks and 14-weeks

• Knee function assessed with the single assessment numeric evaluation method

  Change from baseline to 10-weeks and 14-weeks

• Knee function assessed with the anterior knee pain scale

  Change from baseline to 10-weeks and 14-weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Procedure: Standard Physical Therapy Treatment; Procedure: Return to Running Protocol; Procedure: At Home Exercise Program

Control Group

ACTIVE COMPARATOR

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; Procedure: Return to Running Protocol; Procedure: At Home Exercise Program

Interventions

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.

Experimental Group

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.

Control Group; Experimental Group

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.

Control Group; Experimental Group

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Keller Army Community Hospital - Arvin Physical Therapy

West Point, New York, 10966, United States

Location

Related Publications (1)

• Crowell MS, Brindle RA, Miller EM, Reilly N, Ford KR, Goss DL. The effectiveness of telehealth gait retraining in addition to standard physical therapy treatment for overuse knee injuries in soldiers: a protocol for a randomized clinical trial. Trials. 2023 Oct 16;24(1):672. doi: 10.1186/s13063-023-07502-x.

  PMID: 37845752 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 13, 2020
• Study Start: August 14, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)