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Effectiveness of a Walking Intervention on Impact Loading and Pain

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ClinicalTrials.gov Identifier: NCT04148807
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Northeastern University

Brief Summary:
This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Knee Pain Chronic Behavioral: Gait Retraining Behavioral: Control Not Applicable

Detailed Description:

Knee osteoarthritis (OA) is a chronic condition affecting ~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA.

At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Walking Intervention on Impact Loading and Pain
Estimated Study Start Date : October 28, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participant will receive 8 gait-retraining intervention sessions.
Behavioral: Gait Retraining
During retraining sessions participants will walk on a treadmill at self-selected comfortable walking speed wearing an inertial measurement unit (IMU) on the medial aspect of the distal tibia. The (vertical) peak positive acceleration (PPA) of the tibia is a measure of tibial shock. Subjects will be provided real-time audio feedback to reduce PPA by 20% of their average peak PPA. During retraining sessions, a faded feedback approach will be used. Feedback will be provided continuously during the first four sessions and will be faded over the last 4 sessions. Walking time will increase over the 8 sessions.

Active Comparator: Control
Participant receives 8 sessions of a graded walking program.
Behavioral: Control
The control walking intervention will also be performed on a treadmill where subjects will walk at a self-selected comfortable speed with the same walking times per session as the retraining group without any feedback or retraining cues.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: through study completion, an average of 2 years ]
    # of participants screened per month

  2. Enrollment rate [ Time Frame: through study completion, an average of 2 years ]
    # of participants enrolled per month

  3. Retention [ Time Frame: through study completion, an average of 2 years ]
    % participants that complete all study visits

  4. Compliance [ Time Frame: through study completion, an average of 2 years ]
    Ability to follow instructions to decrease PPA measured by % steps participants are able to keep PPA threshold <80%


Secondary Outcome Measures :
  1. Withdrawals/Terminated [ Time Frame: through study completion, an average of 2 years ]
    Proportion of participants who withdraw or terminated by investigators and reasons why

  2. Adverse events (AE)/Unanticipated problems (UP) [ Time Frame: through study completion, an average of 2 years ]
    Proportion of participants with AE/UP

  3. Vertical average loading rate [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    Slope of the most linear portion of the vertical ground reaction force curve, during early stance.

  4. Vertical instantaneous loading rate [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    Maximum slope of the most vertical portion of the vertical ground reaction force curve between successive data points, during early stance.

  5. Knee Pain with Activities [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    WOMAC questionnaire, pain sub scale 0-20

  6. Knee Pain Severity [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    Visual analog scale, 0-100

  7. Pressure pain threshold [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    Assessed using hand held algometer



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects with a clinical definition of knee OA using NICE guidelines:

  • Age ≥ 45
  • Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
  • History of knee pain for at least 3 months
  • Morning stiffness in the morning lasting less than 30 minutes

Exclusion Criteria:

  • Walk with an assistive device
  • Current use of oral opiates or centrally acting pain medications
  • History of lower extremity surgery
  • Underwent an intra-articular knee joint injection in the past 3 months
  • Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
  • Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study
  • Currently pregnant
  • Skin allergies to adhesives

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): NCT04148807


Contacts
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Contact: Joshua Stefanik, MSPT, PhD 6173738934 j.stefanik@northeastern.edu

Locations
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United States, Massachusetts
Northeastern University Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joshua Stefanik, MSPT, PhD         
Sponsors and Collaborators
Northeastern University

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Responsible Party: Northeastern University
ClinicalTrials.gov Identifier: NCT04148807     History of Changes
Other Study ID Numbers: 18-11-15
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases