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

Not Applicable

Terminated

Interventions: Other: iGetBetter telemedicine physical therapy
Device: CyMedica e-vive™ System; CY-1000

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Group 1, iGetBetter Group	iGetBetter telemedicine physical therapy	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.
Group 2, E-vive Group	CyMedica e-vive™ System; CY-1000	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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