NCT02270684

StepRite Evaluation

Comparative Effectiveness of an Activity-Specific Monitoring Device (StepRite) on Short Term Outcomes in Adults After Total Knee Arthroplasty

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the short-term changes in gait parameters and functional outcomes after total knee arthroplasty between those who use the StepRite device and those who follow a standard therapy program without the device.

Detailed description

Total Knee Arthroplasty (TKA) is a procedure commonly used in severe degeneration of the knee joint due to osteoarthritis. With an increasing number of TKA's performed in a population that is aging during a time where the amount of healthcare dollars allotted to rehabilitation is declining, there is a need to develop remote monitoring of rehabilitation and to engage and optimize self-management of recovery. Current management of TKA recovery is typically performed in the out-patient setting and is highly protocol driven. A typical case might be seen by the physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor progress (i.e. compliance with range of motion (ROM) and strengthening exercises). One recent study suggested that variation in patients' independent exercise and activity after arthroplasty surgery may contribute to variable functional gains. Telerehabilitation is an emerging method of delivering healthcare. It is likely to become more prevalent as technology improves and funding for clinic appointments diminishes. Recent studies have shown that telerehabilitation can be as effective as conventional treatment, as is well tolerated by both patients and healthcare professionals. The StepRite system developed by MedHab (http://www.medhab.com/) allows the physical therapist to monitor physical activity and exercise remotely, thereby reducing the need for frequent out-patient visits. A thin insole placed inside the shoe measures foot contact pressure and a small device attached to the shoe measures acceleration. This information is translated into quantitative feedback about exercise compliance and performance measures comparing the surgical side with the non-surgical side. Real time feedback during exercise and weight-bearing activities is provided to the patient, and a HIPAA secured user interface website also displays this information in an online dashboard for both physical therapists and the physician. Given the potential for improving patient engagement with rehabilitation, this study proposes a treatment model which includes monitoring activity outside of the clinic using the StepRite device and using a combination of outpatient appointments and remote consultations with therapists. Hypothesis Patients who use the device post-surgery will demonstrate superior short-term improvements (i.e. 6 months post TKA) with respect to self-reported functional outcomes and gait parameters, compared to a control group who does not use the device.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	StepRite	The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-21
• Last updated: 2017-05-11
• Results posted: 2017-05-11