Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.

Detailed Description
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Patients undergoing total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. The research assistant (RA) will screen upcoming surgeries and call all qualifying patients to inform them of the study. Those who show interest will be offered the opportunity to discuss with both the RA and Principal Investigator (PI). Upon agreement, the patient's consent will be obtained and they will be randomly assigned to one of three treatment groups using a computer-generated randomization.

Official Title
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Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: CyMedica e-vive™ System; CY-1000
* Other: iGetBetter telemedicine physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Owns a device with internet connection Can download the E-vive application for the contractile garment (has sufficiently up-to-date phone or tablet, or has family member with such a device). Has a rudimentary understanding of Internet technology, especially e-mail Has a flexion of 90 o and flexion contracture of 5 o at the point of discharge Approved by a physical therapist to participate safely in the study at the time of discharge Exclusion Criteria: Rheumatoid arthritis History of epilepsy Implanted and body-worn electronic medical device, including cardiac pacemakers, neural stimulators, insulin pumps, etc. Poor understanding of the use of the brace/electrical stimulation Lesions on the skin over the thigh Uncontrolled diabetes Uncontrolled hypertension Bilateral TKA or UKA planned If female, pregnant Cannot use non-operated leg postoperatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee Loss of sensation in operated or non-operated leg Has below- or above-knee amputations of non-operative leg Below- knee amputation of operated side Chronic pain syndrome with inability to walk Taking chronic narcotics and/or is taking more than 10mg codeine per day, or any Hydrocodone, or more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain Involved in pain clinics for chronic pain, or pain that is not related to the knee Has been diagnosed with knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout, or any inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemi-paralysis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1, iGetBetter Group<br>Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. | Other: iGetBetter telemedicine physical therapy<br>* Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups.<br>|
| Experimental: Group 2, E-vive Group<br>You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. | Device: CyMedica e-vive™ System; CY-1000<br>* All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical.<br>* Other names: Powered Muscle Stimulator or Neuromuscular Electrical Stimulator (NMES); IPF Transcutaneous Nerve Stimulator (TENS) for pain relief; GZJ Goniometer; KQX;|
| No Intervention: Group 3, Physical Therapy Group<br>You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit-to-stand Time | Change in sit-to-stand capabilities | Preoperative (varies) and postoperative appointments (2 months after surgery) | 
| Quadriceps Strength | Change in quadriceps strength in lbs of force, as measured by PT dynamometer | Preoperative and postoperative appointments (2 months after surgery) | 
| 2 Minute Walking Time | Change in distance walked in 2 minutes | Preoperative and postoperative appointments (2 months after surgery) | 
| Walking Speed | Change in walking speed | Preoperative and postoperative appointments (2 months after surgery) | 
| Balancing | Change in proprioception (balance) as measured by 30-second single limb stance PT test | Preoperative and postoperative appointments (2 months after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Pain | Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse | first postoperative months (from days post-op through 2-month post-operative appointment) | 
| Visual Analogue Scale (VAS) Nausea | Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea ) | first postoperative months (from days post-op through 2-month post-operative appointment) | 
| Visual Analogue Scale (VAS) Satisfaction | Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied) | first postoperative months (from days post-op through 2-month post-operative appointment) | 
| Readmission Rate | major complication | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) | 
| Infection Rate | superficial and deep infection | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) | 
| Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT) | We will calculate the total cost of each treatment modality | Completion of study (anticipate one year from start data 4/4/2019) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Physical therapy, Neuromuscular electrical stimulation, Telemedicine