Knee OsteoarthritisNCT02955225
Using Pressure Detecting Insoles to Reduce Knee Loading
A study testing Active Moticon OpenGO insole and Passive shoe insole in people with Knee Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Active Moticon OpenGO insole and Passive shoe insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function
The purpose of this study is to determine whether use of a pressure-detecting shoe improve can enhance favorable loading conditions at the knee.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Active Moticon OpenGO insole, Passive shoe insole
- Keywords
- Knee loads, Knee adduction moment, Biomechanical intervention, Insole, Shoe
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Moticon OpenGO insoleDevice
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
Passive shoe insoleDevice
A deactivated insole measures shoe pressure only.
| Study group | Role | What they receive |
|---|---|---|
| Flexible shoe with Active Insole | Experimental | Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole). Receives: Device: Active Moticon OpenGO insole |
| Flexible shoe with Passive Insole | Active comparator | A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group. Receives: Device: Passive shoe insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: after 3 weeks of ongoing training, after 6 weeks of ongoing training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Sponsor
- Investigators
- Markus Wimmer, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955225
- Sponsor's protocol ID
- AF-6477
- Status last verified
- Feb 2023
- First submitted
- 1 Oct 2016
- Last updated
- 3 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be published through peer reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function
- ClinicalTrials.gov ID
- NCT02955225
- Acronym / sponsor ID
- AF-6477
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee loads, Knee adduction moment, Biomechanical intervention, Insole, Shoe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Oct 2016
- Primary completion
- Aug 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Posted 3 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible shoe with Active Insole | Experimental | Device: Active Moticon OpenGO insoleSubjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole). |
| Flexible shoe with Passive Insole | Active comparator | Device: Passive shoe insoleA flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Moticon OpenGO insoleA Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone. | Device | Flexible shoe with Active Insole |
| Passive shoe insoleA deactivated insole measures shoe pressure only. | Device | Flexible shoe with Passive Insole |
Primary outcome
Change in Knee Adduction Moment Relative to Baseline
Time frame: 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.
4 secondary outcomes
Change in Moment Lever-arm for KAM
Time frame: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Change in SPEED
Time frame: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Change in Knee Pain
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
Time frame: after 3 weeks of ongoing training, after 6 weeks of ongoing training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be published through peer reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Wimmer, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Moticon OpenGO insole and Passive shoe insole in people with Knee Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Adduction Moment Relative to Baseline (time frame: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.