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Using Pressure Detecting Insoles to Reduce Knee Loading

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ClinicalTrials.gov Identifier: NCT02955225
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Active Moticon OpenGO insole Device: Passive shoe insole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function
Study Start Date : October 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Device: Active Moticon OpenGO insole
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.

Active Comparator: Flexible shoe with Passive Insole
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Device: Passive shoe insole
A deactivated insole measures shoe pressure only.




Primary Outcome Measures :
  1. Change in Knee adduction moment [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Surrogate marker of medial knee loading


Secondary Outcome Measures :
  1. Change in knee pain [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Visual analog scale

  2. Change in spatiotemporal parameters [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Speed

  3. Change in self-reported Functional status [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Knee injury and Osteoarthritis Outcome Score

  4. Change in other knee loading parameters [ Time Frame: Baseline, 3 weeks, 6 weeks ]
    Knee Flexion moment and other external moments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02955225


Contacts
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Contact: Chris Ferrigno, PhD 312-563-3868 christopher_ferrigno@rush.edu
Contact: Philip Malloy, MPT 312-942-5814 phillip_malloy@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Markus A Wimmer, PhD    312-942-2789    markus_a_wimmer@rush.edu   
Contact: Christopher Ferrigno, PhD    3125633868    christopher_ferrigno@rush.edu   
Sub-Investigator: Najia Shakoor, MD         
Sponsors and Collaborators
Rush University Medical Center
Arthritis Foundation
Investigators
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Principal Investigator: Markus Wimmer, PhD Rush University Medical Center
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02955225    
Other Study ID Numbers: AF-6477
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be published through peer reviewed journals.
Keywords provided by Rush University Medical Center:
Knee loads
Knee adduction moment
Biomechanical intervention
Insole
Shoe
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases