Using Pressure Detecting Insoles to Reduce Knee Loading

Knee Osteoarthritis Clinical Trial

Official title:

Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955225
• Other study ID #: AF-6477
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2021

Study information

• Verified date: February 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Active Moticon OpenGO insole
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
• Passive shoe insole
A deactivated insole measures shoe pressure only.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
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.	Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
Secondary	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
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	after 3 weeks of ongoing training, after 6 weeks of ongoing training
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)	after 3 weeks of ongoing training, after 6 weeks of ongoing training