Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite - on Short Term Outcomes in Adults After Partial or Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Effectiveness of Step Rite Device
Study Overview
Brief Summary
Partial or Total Knee Arthroplasty are procedures commonly used in severe degeneration of the knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee Arthroplasty 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 Partial or Total Knee Arthroplasty 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 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.
The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert that collects functional data) will reduce cost and improve the efficacy of rehabilitation in total knee arthroplasty patients
Detailed Description
Significance of this study The significance of the proposed study includes the projected benefit to the patients in terms of attaining clinical outcomes quicker and to the medical system in terms of managing cost for the provision of services. Subjects are expected to demonstrate improved compliance to patient tailored rehabilitation protocols which will lead to more rapid attainment of clinical outcomes versus present traditional rehabilitation methodologies. The expected level of, and rate of, attainment of clinical outcomes will translate to an overall reduction of cost to the medical system by reducing the need to engage in additional processes or the need to protract the time required to attain clinical outcomes, where either or both in combination can increase rehabilitation expenditures.
Objectives To compare the efficacy of StepRite in a prescribed physical therapy program verses traditional in-facility physical therapy program after partial or total knee replacement surgery using validated survey tools to evaluate patient progress, including patient self -reporting of progress and surgeon appraisal of patient performance post-operatively.
To compare the overall cost of post-operative rehabilitation of patients involved in traditionally employed regimens versus those using the StepRite device.
Hypothesis and specific aims The aim of this study is to evaluate whether improved clinical outcomes as well as reduction in cost in provision of care can be better affected through the use of the Steprite device as compared to the use of traditional rehabilitation modalities.
The Investigators will seek to reject the null hypotheses that 1) there is no difference between clinical outcomes attained between patients using the Steprite device and those using traditional rehabilitation modalities and that 2) there is no reduction in cost to the medical system when patients use Steprite versus other conventional methods of rehabilitation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Unilateral partial or total knee arthroplasty.
- •Age 45-75 yr. old
- •Access to Wi-Fi
- •Have appropriate smart phone and knowledge of use
- •Be willing to place StepRite app on their personal phone
Exclusion Criteria
- •History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).
- •Pregnancy
- •History of cognitive disease that would preclude ability to navigate smart phone
Arms & Interventions
Active Comparator Steprite™ Device'
steprite™ device active Comparator- The steprite™ System is a monitoring and biofeedback system for the Monitoring of rehabilitation patients Measuring pressure distribution, gait and range of motion of the lower extremities while a patient performs specified rehabilitation exercises
Intervention: Steprite™ (Device)
Control
Control outcomes with no device. Standard of care physical therapy and outcomes.
Intervention: Standard of care (Other)
Outcomes
Primary Outcomes
Effectiveness of Step Rite Device
Time Frame: 3 months
Effectiveness of outcomes with the use of the StepRite device
Secondary Outcomes
No secondary outcomes reported