StepRite Evaluation

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02270684
• Other study ID #: FP00002312
• Secondary ID: HS-13-00319
• Status: Not yet recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: October 17, 2014
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2014
• Source: University of Southern California
• Contact: Christopher Powers, PhD
• Phone: 3234422900
• Email: powers[@]usc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Unilateral total knee arthroplasty performed under regional (spinal +/- epidural) or general anesthesia. Surgical approach via an anterior 4-6 inch incision and utilizing a medial parapatellar arthrotomy incision. Posterior stabilized total knee arthroplasty decision.

• Age 55-75 yr. old

• BMI <35

Exclusion Criteria:

• History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).

• Contralateral degenerative joint disease requiring a TKA.

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Osteoarthritis Outcome Score (KOOS)	The KOOS is a validated tool to measure pain and quality of life in patients after TKA	Baseline, 4, 10, 24 weeks	No