21
Participants
Start Date
April 4, 2019
Primary Completion Date
January 17, 2022
Study Completion Date
January 17, 2022
CyMedica e-vive™ System; CY-1000
"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."
iGetBetter telemedicine physical therapy
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
Collaborators (1)
CyMedica Orthopedics, Inc
INDUSTRY
Wolfgang Fitz, M.D.
OTHER