Back to resultsUsing Pressure Detecting Insoles to Reduce Knee Loading
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Moticon OpenGO insole
Passive shoe insole
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee loads, Knee adduction moment, Biomechanical intervention, Insole, Shoe
Eligibility Criteria
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.
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flexible shoe with Active Insole
Flexible shoe with Passive Insole
Arm Description
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in SPEED
A change in Speed (m/s) after 3 and 6 weeks of training with insoles.
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
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)
Full Information
NCT ID
NCT02955225
First Posted
October 1, 2016
Last Updated
February 3, 2023
Sponsor
Rush University Medical Center
Collaborators
Arthritis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02955225
Brief Title
Using Pressure Detecting Insoles to Reduce Knee Loading
Official Title
Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
September 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Arthritis Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee loads, Knee adduction moment, Biomechanical intervention, Insole, Shoe
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexible shoe with Active Insole
Arm Type
Experimental
Arm Description
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Arm Title
Flexible shoe with Passive Insole
Arm Type
Active Comparator
Arm Description
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Intervention Type
Device
Intervention Name(s)
Active Moticon OpenGO insole
Intervention Description
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
Intervention Type
Device
Intervention Name(s)
Passive shoe insole
Intervention Description
A deactivated insole measures shoe pressure only.
Primary Outcome Measure Information:
Title
Change in Knee Adduction Moment Relative to Baseline
Description
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
Secondary Outcome Measure Information:
Title
Change in Moment Lever-arm for KAM
Description
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
Title
Change in SPEED
Description
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
Title
Change in Knee Pain
Description
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
Title
Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Wimmer, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be published through peer reviewed journals.
IPD Sharing Time Frame
Dec 31, 2021
IPD Sharing Access Criteria
Sharing access through the Arthritis Foundation
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Using Pressure Detecting Insoles to Reduce Knee Loading
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