Video Telehealth Gait Retraining for Running-Related Knee Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04269473
• Other study ID #: 19KACH004
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Keller Army Community Hospital
• Contact: Michael Crowell, PT, DSc
• Phone: 8459383067
• Email: michael.s.crowell.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee
• Pain
• Running
• Telemedicine

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Keller Army Community Hospital - Arvin Physical Therapy	West Point	New York

Sponsors (2)

Lead Sponsor	Collaborator
Keller Army Community Hospital	Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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