Effectiveness of a Walking Intervention on Impact Loading and Pain

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; Knee Pain Chronic
• Interventions: Behavioral: Progressive Walking Program; Behavioral: Progressive Walking with Gait Retraining

• Registration Number: NCT04148807
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-04
• Study Start: 2019-11-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive walking program	Progressive Walking Program	Participant receives 8 sessions of a graded walking program.
Progressive walking program with gait retraining	Progressive Walking with Gait Retraining	Participant will receive 8 gait-retraining intervention sessions.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Withdrawals/Terminated	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)	through study completion, an average of 2 years	Proportion of participants with AE/UP
Vertical average loading rate	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	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	Change from baseline to conclusion of intervention, an average of 1-month	WOMAC questionnaire, pain sub scale 0-20
Knee Pain Severity	Change from baseline to conclusion of intervention, an average of 1-month	Visual analog scale, 0-100
Pressure pain threshold	Change from baseline to conclusion of intervention, an average of 1-month	Assessed using hand held algometer

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States