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 : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Knee Pain Chronic||Behavioral: Gait Retraining Behavioral: Control||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of a Walking Intervention on Impact Loading and Pain|
|Actual Study Start Date :||November 5, 2019|
|Estimated Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||May 30, 2022|
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.
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.
- 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
- 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
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
|Contact: Joshua Stefanik, MSPT, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Contact: Joshua Stefanik, MSPT, PhD|