Physical Therapy, Reverse Total Shoulder Arthroplasty
Conditions
Brief summary
This is a trial comparing self-directed rehabilitation using the Zimmer Biomet mymobility digital platform versus standard office-based physical therapy after reverse shoulder replacement. The investigators hypothesize that there will be no difference in the postoperative outcomes between the mymobility cohort and the standard office-based physical therapy cohort.
Detailed description
This is a prospective, multicenter, randomized controlled trial comparing a self-directed rehabilitation protocol using the Zimmer Biomet mymobility digital platform versus standard office based physical therapy protocol after reverse total shoulder arthroplasty. Subjects will be randomly assigned to the Treatment Cohort (mymobility Physical Therapy) or the Control Cohort (Standard Office-based Physical Therapy). Randomization will occur following completion of a signed consent form. Each Participating Site will receive sealed, numbered randomization envelopes from the Lead Site. The treatment cohort is mymobility PT. If the subject is randomized to this cohort, the Participating Site will assist the subject to download the mymobility mobile application (app) during the preoperative visit. The app has a video of each of the exercises to be completed per phase of the rehabilitation protocol beginning on postop day one. The control cohort is Standard office PT. Home exercises begin on postoperative day one with office visits beginning after the 2 week postoperative visit. Subject data will be collected through the 6-month postoperative visit.
Interventions
OTHERmymobility Physical Therapy
Physical therapy protocol administered at home through the mymobility application.
OTHERStandard Office-based Physical Therapy
Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist.
Sponsors
American Shoulder and Elbow Surgeons
Campbell Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Primary Reverse Total Shoulder Arthroplasty performed for diagnosis of cuff tear arthropathy (CTA), massive rotator cuff tears (mRCT), osteoarthritis (OA), or inflammatory arthritis (IA). * Have a functioning smartphone model compatible with the mymobility platform.
Exclusion criteria
* Less than 18 years of age. * Revision Reverse Total Shoulder Arthroplasty * Concomitant tendon transfer * Planned discharge to inpatient rehab facility, skilled nursing home, or use of home health therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score | 6 months | The ASES Standardized Shoulder Assessment Score outputs a measurement of patient pain and function on a scale of 0 to 100, with 0 being the greatest pain and no function and 100 being no pain and perfect function. |
Countries
United States
Outcome results
None listed