NCT02955225

Using Pressure Detecting Insoles to Reduce Knee Loading

Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Active Moticon OpenGO insole	A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
DEVICE	Passive shoe insole	A deactivated insole measures shoe pressure only.

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-08-01
• Completion: 2021-09-01
• First posted: 2016-11-04
• Last updated: 2023-03-03
• Results posted: 2023-03-03

Locations

1 site across 1 country: United States