Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Video Telehealth Gait Retraining for Running-Related Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269473
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Keller Army Community Hospital

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.

Condition or disease Intervention/treatment Phase
Telemedicine Running Knee Pain Procedure: Telehealth Gait Retraining Procedure: Standard Physical Therapy Treatment Procedure: Return to Running Protocol Procedure: At Home Exercise Program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269473


Contacts
Layout table for location contacts
Contact: Michael Crowell, PT, DSc 8459383067 michael.s.crowell.mil@mail.mil

Locations
Layout table for location information
United States, New York
Keller Army Community Hospital - Arvin Physical Therapy
West Point, New York, United States, 10966
Contact: Michael Crowell, PT, DSc    845-938-3067    michael.s.crowell.mil@mail.mil   
Sponsors and Collaborators
Keller Army Community Hospital
Uniformed Services University of the Health Sciences

Layout table for additonal information
Responsible Party: Keller Army Community Hospital
ClinicalTrials.gov Identifier: NCT04269473    
Other Study ID Numbers: 19KACH004
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No