Using Pressure Detecting Insoles to Reduce Knee Loading

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02955225

Collaborator

Arthritis Foundation (Other)

109

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: Active Moticon OpenGO insole Device: Passive shoe insole	N/A

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

Study Type:

Interventional

Actual Enrollment :

109 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 :

Oct 1, 2016

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Knee adduction moment [Baseline, 3 weeks, 6 weeks]
Surrogate marker of medial knee loading

Secondary Outcome Measures

Change in knee pain [Baseline, 3 weeks, 6 weeks]
Visual analog scale
Change in spatiotemporal parameters [Baseline, 3 weeks, 6 weeks]
Speed
Change in self-reported Functional status [Baseline, 3 weeks, 6 weeks]
Knee injury and Osteoarthritis Outcome Score
Change in other knee loading parameters [Baseline, 3 weeks, 6 weeks]
Knee Flexion moment and other external moments

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.