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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
21
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.
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.
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States
Sit-to-stand Time
Change in sit-to-stand capabilities
Time frame: Preoperative (varies) and postoperative appointments (2 months after surgery)
Quadriceps Strength
Change in quadriceps strength in lbs of force, as measured by PT dynamometer
Time frame: Preoperative and postoperative appointments (2 months after surgery)
2 Minute Walking Time
Change in distance walked in 2 minutes
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Walking Speed
Change in walking speed
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Balancing
Change in proprioception (balance) as measured by 30-second single limb stance PT test
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Visual Analogue Scale (VAS) Pain
Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse
Time frame: 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 )
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Satisfaction
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Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Readmission Rate
major complication
Time frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Infection Rate
superficial and deep infection
Time frame: 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
Time frame: Completion of study (anticipate one year from start data 4/4/2019)