Osteoarthritis
Conditions
Keywords
Total Knee Arthroplasty, Home monitoring
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.
Interventions
DEVICEStepRite
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
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Osteoarthritis Outcome Score (KOOS) | Baseline, 4, 10, 24 weeks | The KOOS is a validated tool to measure pain and quality of life in patients after TKA |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 1 |
| Usual and Customary Care Participants in this arm will undergo usual care and will not be issued with the StepRite device | 3 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Study terminated | 1 | 0 |
Baseline characteristics
| Characteristic | Device | Usual and Customary Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
Knee Osteoarthritis Outcome Score (KOOS)
The KOOS is a validated tool to measure pain and quality of life in patients after TKA
Time frame: Baseline, 4, 10, 24 weeks
Population: Due to early termination, no evaluable data was collected