Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty, Rotator Cuff Tears
Conditions
Keywords
physical therapy compliance, home-based physical therapy
Brief summary
Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the procedure. The purpose of this research is to investigate the effectiveness of Band Connect, a connected health platform, in enhancing compliance with home exercise programs among patients undergoing physical therapy. This study aims to evaluate the implications of increased compliance on improving patient engagement and increasing satisfaction for both patients and clinicians. Additionally, the study will analyze the economic implications of implementing Band Connect's hybrid care model on driving increased revenue per patient.
Interventions
DEVICEBand Connect
Band Connect provides a medical-grade and condition-specific platform that augments the clinician workflow by extending the in-clinic MSK rehabilitation experience into the patient's home - leading to higher quality personalized treatment and increased adherence with enhanced economics and reimbursement for the clinic.
Sponsors
University Hospitals Cleveland Medical Center
Band Connect
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age range: from 18 to 89 years old * Surgery performed by Dr. Robert Gillespie and will be undergoing post-op physical therapy rehabilitation at University Hospitals * Patients undergoing primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA) * Patients undergoing primary rotator cuff repair * Prescribed outpatient physical therapy for post-operative rehabilitation Chart Review Inclusion Criteria: * Age range: from 18 to 89 years old * Surgery performed by Dr. Robert Gillespie who underwent post-op physical therapy rehabilitation at University Hospitals * Patients who underwent primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA) * Patients who underwent primary rotator cuff repair * Prescribed outpatient physical therapy for post-operative rehabilitation
Exclusion criteria
* Patients undergoing hemiarthroplasty or revision TSA * Patients undergoing revision rotator cuff repair * TSA performed for proximal humerus fractures * Length of stay in hospital following shoulder surgery greater than 3 days * Shoulder injuries related to workers compensation or involved in any pending litigation * Pregnant individuals Chart Review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of physical therapy visits as measured by medical record review. | Up to 6 months | — |
| Number of home exercise programs completed as measured by medical record review. | Up to 6 months | — |
| Number of in clinic visits as measured by medical record review. | Up to 6 months | — |
| Number of patients who were able to return to work | Up to 6 months | This will be asked as a Yes/No question |
| Time to return to work measured in weeks | Up to 6 months | — |
| Number of patients who returned to sports | Up to 6 months | This will be asked as a Yes/No question |
| Change in pain as measured by the Visual Analog Scale | Baseline, 1 month, 3 months, 6 months | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). |
| Active range of motion measured in degrees | Up to 6 months | — |
| Passive range of motion measured in degrees | Up to 6 months | — |
| Strength will be measured on a scale of 0-5 | Up to 6 months | Strength scale: * 0: no visible or palpable contraction * 1: visible or palpable contraction without motion * 2: full range of motion, gravity eliminated * 3: full range of motion against gravity * 4: full range of motion against gravity, moderate resistance * 5: full range of motion against gravity, maximal resistance |
| Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score | Up to 6 months | Scored out of 100, with higher scores indicating greater satisfaction |
| Number of adverse events as measured by medical record review. | Up to 6 months | — |
Countries
United States
Contacts
CONTACTKira Smith, MD
PRINCIPAL_INVESTIGATORRobert Gillespie
University Hospitals Cleveland Medical Center
Outcome results
None listed