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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

Tracking Information
First Submitted Date  ICMJE October 29, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date November 6, 2019
Estimated Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Recruitment rate [ Time Frame: through study completion, an average of 2 years ]
    # of participants screened per month
  • Enrollment rate [ Time Frame: through study completion, an average of 2 years ]
    # of participants enrolled per month
  • Retention [ Time Frame: through study completion, an average of 2 years ]
    % participants that complete all study visits
  • 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%
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04148807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Withdrawals/Terminated [ Time Frame: through study completion, an average of 2 years ]
    Proportion of participants who withdraw or terminated by investigators and reasons why
  • Adverse events (AE)/Unanticipated problems (UP) [ Time Frame: through study completion, an average of 2 years ]
    Proportion of participants with AE/UP
  • 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.
  • 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.
  • 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
  • Knee Pain Severity [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    Visual analog scale, 0-100
  • Pressure pain threshold [ Time Frame: Change from baseline to conclusion of intervention, an average of 1-month ]
    Assessed using hand held algometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Walking Intervention on Impact Loading and Pain
Official Title  ICMJE Effectiveness of a Walking Intervention on Impact Loading and Pain
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Knee Pain Chronic
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention
    Participant will receive 8 gait-retraining intervention sessions.
    Intervention: Behavioral: Gait Retraining
  • Active Comparator: Control
    Participant receives 8 sessions of a graded walking program.
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joshua Stefanik, MSPT, PhD 6173738934 j.stefanik@northeastern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04148807
Other Study ID Numbers  ICMJE 18-11-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northeastern University
Study Sponsor  ICMJE Northeastern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northeastern University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP