Knee Pain Chronic, Osteoarthritis, Knee
Conditions
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.
Interventions
BEHAVIORALProgressive 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.
BEHAVIORALProgressive 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.
Sponsors
Northeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Withdrawals/Terminated | through study completion, an average of 2 years | Proportion of participants who withdraw or terminated by investigators and reasons why |
| Pressure pain threshold | Change from baseline to conclusion of intervention, an average of 1-month | Assessed using hand held algometer |
| Knee Pain Severity | Change from baseline to conclusion of intervention, an average of 1-month | Visual analog scale, 0-100 |
| 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. |
Countries
United States
Contacts
Primary ContactJoshua Stefanik, MSPT, PhD
Outcome results
None listed