Effectiveness of a Walking Intervention on Impact Loading and Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Knee Pain Chronic
• Intervention / Treatment: Behavioral: Progressive Walking with Gait Retraining; Behavioral: Progressive Walking Program

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.

Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Stefanik, MSPT, PhD; Phone Number: 6173738934; Email: j.stefanik@northeastern.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Northeastern University
      • Contact: Joshua Stefanik, MSPT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Progressive walking program with gait retraining; Participant will receive 8 gait-retraining intervention sessions.	Behavioral: Progressive Walking with Gait Retraining; A progressive walking program with gait retraining will be performed 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: Progressive walking program; Participant receives 8 sessions of a graded walking program.	Behavioral: Progressive Walking Program; A progressive walking program 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	# of participants screened per month	through study completion, an average of 2 years
Enrollment rate	# of participants enrolled per month	through study completion, an average of 2 years
Retention	% participants that complete all study visits	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawals/Terminated	Proportion of participants who withdraw or terminated by investigators and reasons why	through study completion, an average of 2 years
Adverse events (AE)/Unanticipated problems (UP)	Proportion of participants with AE/UP	through study completion, an average of 2 years
Vertical average loading rate	Slope of the most linear portion of the vertical ground reaction force curve, during early stance.	Change from baseline to conclusion of intervention, an average of 1-month
Vertical instantaneous loading rate	Maximum slope of the most vertical portion of the vertical ground reaction force curve between successive data points, during early stance.	Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain with Activities	WOMAC questionnaire, pain sub scale 0-20	Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain Severity	Visual analog scale, 0-100	Change from baseline to conclusion of intervention, an average of 1-month
Pressure pain threshold	Assessed using hand held algometer	Change from baseline to conclusion of intervention, an average of 1-month

Collaborators and Investigators

• Sponsor: Northeastern University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2019
• Primary Completion (ANTICIPATED): March 30, 2023
• Study Completion (ANTICIPATED): March 30, 2023

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (ACTUAL): November 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 18-11-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No