The purpose of this study is to determine whether use of a pressure-detecting shoe improve can enhance favorable loading conditions at the knee.
This is a randomized longitudinal proof-of-concept study. After a telephone prescreening, an in-person visit will screen for inclusion and exclusion criteria, requiring a clinical and radiographic assessment. A total of 40 subjects with symptomatic and radiographic medial knee OA will be enrolled in the study after obtaining informed consent. A total of three study visits will occur at the following time points: baseline, 3 weeks, and 6 weeks. At all three visits, the following outcome variables will be acquired: (1) joint loads during gait using 3D motion analysis and (2) knee symptoms, stiffness, pain, daily function, recreational function, and quality of life using the validated questionnaires. At the baseline visit, every participant will receive a standardized shoe and a pressure-detecting shoe insole. Randomly assigned to one of two groups, participants assigned to group A (n=25) will train for 3 weeks in the mobility shoe with active pressure-based feedback from the shoe insole, and group B (n=15) will train for three weeks in the mobility shoe with a passive shoe insole. All subjects will be encouraged to wear the study shoes containing the shoe insoles as their primary form of footwear and for a minimum of 6 hours/day, 6 days/week. They will be given a diary to record the daily time spent wearing the shoe/insole, daily analgesic history, and adverse events. These diaries will be reviewed at the 3 and 6 week study visits. After completing the third visit, subjects will have completed the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
A deactivated insole measures shoe pressure only.
Rush University Medical Center
Chicago, Illinois, United States
Change in Knee Adduction Moment Relative to Baseline
Surrogate marker of medial knee loading, measured using 3D motion analysis, with initial SI units in Newton\*meters, and normalized to the individual's body weight and height, resulting in measurement units (% bodyweight \* height). To assess changes in loading at the knee between baseline and the three post-baseline measurements (Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training), participants underwent gait analysis in a motion analysis laboratory using force plates and optoelectric cameras to quantify the joint moments in three directions. This study focused on the change in joint moment in the frontal plane. After training with an active insole, we would expect reductions in the frontal plane knee joint moment. Generally speaking, lower moments are better and a negative change is desired.
Time frame: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Change in Moment Lever-arm for KAM
To further assess changes in loading at the knee between baseline and the three post-baseline measurements (Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training), participants underwent gait analysis in a motion analysis laboratory using force plates and optoelectric cameras to quantify joint moment. One component which determines the knee moment is the lever-arm between ground reaction force vector and the center of the knee joint, in the frontal plane, which is measured in millimeters.
Time frame: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Change in SPEED
A change in Speed (m/s) after 3 and 6 weeks of training with insoles.
Time frame: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Change in Knee Pain
To assess a change pain, participants completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and after 3 and 6 weeks of training with insoles; 0 representing extreme problems and 100 representing no problems
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Time frame: after 3 weeks of ongoing training, after 6 weeks of ongoing training
Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training
To assess a change self-reported Functional status, participants completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and after 3 and 6 weeks of training with insoles; 0 representing extreme problems and 100 representing no problems with Function in daily living, with a score of 100 as the optimal outcome with unlimited function. (change between baseline and 3 weeks, and the change between baseline and 6 weeks)
Time frame: after 3 weeks of ongoing training, after 6 weeks of ongoing training