Improving at-home shoulder rehab with BAND Connect's VirtuaCare platform.
Measuring the Effectiveness of BAND Connect's VirtuaCare™ Asynchronous Telerehabilitation Platform in Increasing Patient Adherence for Total Shoulder Arthroplasty and Rotator Cuff Repair Physical Therapy Rehabilitatio
This project will test whether the BAND Connect VirtuaCare app and sensor handles help people recovering from rotator cuff repair or shoulder replacement stick to and correctly do their home exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05876208 on ClinicalTrials.gov |
What this trial studies
This randomized study will enroll patients undergoing primary rotator cuff repair or primary total/reverse shoulder arthroplasty performed by Dr. Brian Grawe and receiving outpatient physical therapy at UC Health. Participants are randomly assigned to either use the BAND CVCP (VirtuaCare) system in clinic and at home or to receive standard physical therapy alone. The VirtuaCare system provides step-by-step exercise instructions, real-time biofeedback on form, range of motion, pace, and exertion via sensor-equipped handles, and generates participant reports for therapists to review. Outcomes include adherence to prescribed at-home exercises and patient-reported pain and function measured at pre-op, weekly visual analog scales, and monthly follow-ups.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing primary rotator cuff repair or primary anatomic or reverse total shoulder arthroplasty by Dr. Brian Grawe who will receive outpatient physical therapy at UC Health.
Not a fit: Patients undergoing revision or partial shoulder procedures, fracture surgeries, those with recent prior shoulder surgery, uncontrolled comorbidities (for example uncontrolled diabetes or recent cancer), workers' compensation cases, or anyone unable to attend UC Health visits or use the provided device and Android phone are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the technology could help patients complete more of their prescribed home exercises with better form, which may speed or improve functional recovery.
How similar studies have performed: Prior small trials of sensor-guided home rehabilitation and tele-rehab have reported improved adherence and some functional gains, but larger randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Dr. Brian Grawe will perform surgery, and participants will be undergoing post-operative physical therapy rehabilitation at UC Health. * Primary total shoulder arthroplasty and primary reverse total shoulder arthroplasty or Primary rotator cuff repair * Outpatient physical therapy prescribed by the doctor for post-operative rehabilitation Exclusion Criteria: * Unplanned surgical procedure * Partial shoulder replacement or revision shoulder replacement * Revision rotator cuff repair * Fracture surgeries * Prior surgery within the last 5 years or less than 6 months between surgery on opposite shoulder * Length of stay in hospital greater than 3 days * Comorbidity: Uncontrolled diabetes patients; Diagnosed with cancer in the past 5 years or active disease; Any comorbidity that may impact compliance with the study protocol (completion of standard physical therapy rehabilitation procedures) * Injuries related to workers' compensation * Injuries involved in any pending litigation
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Brian M Grawe, MD — University of Cincinnati
- Study coordinator: Kim Hasselfeld
- Email: hasselky@uc.edu
- Phone: 513-558-1933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.