StepRite Evaluation

NCT ID: NCT02270684

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Device

Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment

Group Type: EXPERIMENTAL

StepRite

Intervention Type: DEVICE

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

Usual and customary care

Participants in this arm will undergo usual care and will not be issued with the StepRite device

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Christopher Powers

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Powers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Other Identifiers

HS-13-00319

Identifier Type: OTHER

Identifier Source: secondary_id

FP00002312

Identifier Type: -

Identifier Source: org_study_id