Study of the KinexConnect Telerehabilitation System (KCTRS)

Study Overview
=================
Brief Summary
-----------------
A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA).

Detailed Description
-----------------
The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.

Official Title
-----------------
Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.
* Behavioral: Traditional outpatient PT for rehabilitation after TKA.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned for a primary unilateral TKA. At least 21 years of age. Capable of understanding the study requirements and giving written informed consent. Willing and able to comply with either therapy program. Has easy access to caregiver support. Exclusion Criteria: Active range-of-motion (ARoM) < 80 degrees in target knee. Unable to read and write in English. Lack of email capability to receive recovery trend information. Previous knee intervention in target knee. Previous knee joint infection in either knee. Received a revision TKA (opposite knee). Planned for bilateral TKA. Self-reported pregnancy. Reason for arthroplasty being for the treatment of fracture, infection or malignancy. Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed. Unwilling to participate.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KinexConnect<br>Rehab at Home Patients | Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.<br>* KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.<br>|
| Active Comparator: Outpatient PT<br>In-person PT patients | Behavioral: Traditional outpatient PT for rehabilitation after TKA.<br>* Control subjects are asked to undergo standard outpatient physical therapy (PT) with a licensed physical therapist plus supplemental home exercises as directed. Nominally patients are expected to have 3 PT sessions per week for 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Timed up and Go (TUG) Test score | The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better. | 3 months | 
| Change in the Timed up and Go (TUG) Test score | The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better. | 1 year | 
| Economic Benefit | Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available. | 3 months | 
| Economic Benefit | Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Active Range of Motion (ARoM) | Active Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve with independent effort | 3 months and 6 months | 
| Change in Passive Range of Motion (PRoM) | Passive Range of Motion is the difference between the maximum Flexion and maximum Extension the patient is able to achieve when bearable force is exerted by the clinician. | 3 months and 6 months | 
| Change in Pain as measured by the Verbal Descriptive Scale (VDS) | This is a self reported outcome by the patient based on their expression of pain at a given time point when presented with the 7 verbal cues. The levels of pain reported vary from No Pain to Most Intense Pain Imaginable. Higher the intensity of pain, worse the outcome | 3 months and 1 year | 
| Change in the Knee Osteoarthritis Outcome Score (KOOS) | The KOOS is a standardized and validated patient outcome score that assess functional limitation in patient with knee osteoarthritis. The survey questionnaire is filled out in its entirety by the patient. The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | 3 months and 1 year | 
| Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation | The patient satisfaction and patient expectation scores are calculated by having the relevant sections of the survey questionnaire is filled out in its entirety by the patient. Patient Satisfaction is scored 0 - 40 points and Patient Expectation is scored 0 -15 points. with Zero being the worst outcome. | 3 months and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKR, Arthroplasty, Knee Replacement, Rehab at home, Virtual PT, Remote Patient Monitoring, Patient Engagement, TKA