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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.
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.
Des Moines Orthopedic Surgeons
Des Moines, Iowa, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
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
Time frame: 3 months and 6 months
Change in Passive Range of Motion (PRoM)
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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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 3 months and 1 year