Using Pressure Detecting Insoles to Reduce Knee Loading

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Active Moticon OpenGO insole; Device: Passive shoe insole

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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)	after 3 weeks of ongoing training, after 6 weeks of ongoing training

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Arthritis Foundation

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: October 1, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Shoe; Insole; Knee adduction moment; Knee loads; Biomechanical intervention
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AF-6477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL