Knee Osteoarthritis
Conditions
Keywords
Knee loads, Knee adduction moment, Biomechanical intervention, Insole, Shoe
Brief summary
The purpose of this study is to determine whether use of a pressure-detecting shoe improve can enhance favorable loading conditions at the knee.
Detailed description
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.
Interventions
DEVICEActive Moticon OpenGO insole
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
DEVICEPassive shoe insole
A deactivated insole measures shoe pressure only.
Sponsors
Arthritis Foundation
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to give informed consent and comply with the study protocol. * Symptomatic OA of the knee greater than 3 months, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified as more symptomatic will serve as the index knee. * Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC). * Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale. * Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte. * Able to walk at least 10 minutes without a break. * Age of 40 years or older
Exclusion criteria
* Unwillingness to wear study shoes for at least 6 hours/day for 6 days of the week * Knee flexion contracture of \> 15 degrees or inability to ambulate without assistance. * Presence of clinical OA of the ankle or hip or ankle/hip pain\>10 mm (WOMAC). * Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either knee. * Concurrent systemic inflammatory arthropathy * Prior knee or hip arthroplasty, or surgical arthroscopy within the previous 3 months. * Intrinsic foot disease: hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated particular footwear. * Intra-articular knee injection: steroids within 6 wks, hyaluronan derivatives within 4 mos. * Body mass index greater than 38.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Adduction Moment Relative to Baseline | Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Moment Lever-arm for KAM | Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training | 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. |
| Change in SPEED | Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training | A change in Speed (m/s) after 3 and 6 weeks of training with insoles. |
| Change in Knee Pain | after 3 weeks of ongoing training, after 6 weeks of ongoing training | 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 |
| Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training | after 3 weeks of ongoing training, after 6 weeks of ongoing 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flexible Shoe With Active Insole Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone. | 26 |
| Flexible Shoe With Passive Insole A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only. | 12 |
| Total | 38 |
Baseline characteristics
| Characteristic | Flexible Shoe With Active Insole | Flexible Shoe With Passive Insole | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 8 | 63 years STANDARD_DEVIATION 9 |
| Knee Adduction Moment (KAM1) | 3.21 %bodyweight x height STANDARD_DEVIATION 0.99 | 3.27 %bodyweight x height STANDARD_DEVIATION 0.97 | 3.27 %bodyweight x height STANDARD_DEVIATION 0.91 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 26 Participants | 12 Participants | 38 Participants |
| Sex: Female, Male Female | 22 Participants | 8 Participants | 30 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 12 |
| other Total, other adverse events | 0 / 26 | 0 / 12 |
| serious Total, serious adverse events | 0 / 26 | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Flexible Shoe With Active Insole | Change in Knee Adduction Moment Relative to Baseline | Immediate | -0.21 percentage of bodyweight x height |
| Flexible Shoe With Active Insole | Change in Knee Adduction Moment Relative to Baseline | 3 weeks | -0.21 percentage of bodyweight x height |
| Flexible Shoe With Active Insole | Change in Knee Adduction Moment Relative to Baseline | 6 weeks (washout) | -0.12 percentage of bodyweight x height |
| Flexible Shoe With Passive Insole | Change in Knee Adduction Moment Relative to Baseline | Immediate | -0.09 percentage of bodyweight x height |
| Flexible Shoe With Passive Insole | Change in Knee Adduction Moment Relative to Baseline | 3 weeks | -0.24 percentage of bodyweight x height |
| Flexible Shoe With Passive Insole | Change in Knee Adduction Moment Relative to Baseline | 6 weeks (washout) | -0.12 percentage of bodyweight x height |
Secondary
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
Time frame: after 3 weeks of ongoing training, after 6 weeks of ongoing training
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Flexible Shoe With Active Insole | Change in Knee Pain | 3 week time point | 4.3 units on a scale from 0 to 100 |
| Flexible Shoe With Active Insole | Change in Knee Pain | 6 week time point | 7.0 units on a scale from 0 to 100 |
| Flexible Shoe With Passive Insole | Change in Knee Pain | 3 week time point | 10.0 units on a scale from 0 to 100 |
| Flexible Shoe With Passive Insole | Change in Knee Pain | 6 week time point | 12.3 units on a scale from 0 to 100 |
Secondary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Flexible Shoe With Active Insole | Change in Moment Lever-arm for KAM | Immediate | -6 mm (millimeters) |
| Flexible Shoe With Active Insole | Change in Moment Lever-arm for KAM | 3 weeks | -5 mm (millimeters) |
| Flexible Shoe With Active Insole | Change in Moment Lever-arm for KAM | 6 weeks (washout) | -2 mm (millimeters) |
| Flexible Shoe With Passive Insole | Change in Moment Lever-arm for KAM | Immediate | 1 mm (millimeters) |
| Flexible Shoe With Passive Insole | Change in Moment Lever-arm for KAM | 3 weeks | 3 mm (millimeters) |
| Flexible Shoe With Passive Insole | Change in Moment Lever-arm for KAM | 6 weeks (washout) | 3 mm (millimeters) |
Secondary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Flexible Shoe With Active Insole | Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training | 3 weeks | 8.5 units on a scale, from 0 to 100 |
| Flexible Shoe With Active Insole | Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training | 6 weeks | 15.6 units on a scale, from 0 to 100 |
| Flexible Shoe With Passive Insole | Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training | 3 weeks | 8.5 units on a scale, from 0 to 100 |
| Flexible Shoe With Passive Insole | Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training | 6 weeks | 6.7 units on a scale, from 0 to 100 |
Secondary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Flexible Shoe With Active Insole | Change in SPEED | Immediate | -.09 Meters/sec |
| Flexible Shoe With Active Insole | Change in SPEED | 3 weeks | -.04 Meters/sec |
| Flexible Shoe With Active Insole | Change in SPEED | 6 weeks (washout) | -.01 Meters/sec |
| Flexible Shoe With Passive Insole | Change in SPEED | Immediate | .05 Meters/sec |
| Flexible Shoe With Passive Insole | Change in SPEED | 3 weeks | .08 Meters/sec |
| Flexible Shoe With Passive Insole | Change in SPEED | 6 weeks (washout) | .06 Meters/sec |