VirtuaCare™ Platform for Shoulder Injuries

Overseen By Michael Kloby

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Uncontrolled diabetes, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to enhance at-home therapy by introducing a new device called the BAND Connect's VirtuaCare™ platform. The study aims to determine whether patients can improve their adherence to at-home exercises using this device. Currently, research indicates that only 35% of patients undergoing physical therapy treatment fully comply with their prescribed plans of care, often neglecting their at-home exercises. To address this issue, a set of smart exercise tools called VirtuaCare™ has been developed. This platform provides patients with instructions on performing at-home exercises and offers real-time biofeedback to help them adjust their form if necessary. The study seeks to evaluate the effectiveness of BAND CVCP in assisting patients and improving their overall success with at-home therapy.

Research Team

Brian M Grawe, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for patients who have had shoulder surgery performed by Dr. Brian Grawe and are prescribed outpatient physical therapy at UC Health. It's specifically for those with primary total or reverse total shoulder arthroplasty, or primary rotator cuff repair.

Inclusion Criteria

Dr. Grawe will perform my surgery, and I'll have rehab at UC Health.

My doctor has prescribed outpatient physical therapy for after my surgery.

I am having or have had a primary shoulder replacement or rotator cuff repair.

Exclusion Criteria

I was in the hospital for more than 3 days.

I am having a second surgery on my rotator cuff.

Injuries related to workers' compensation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive physical therapy with or without the BAND CVCP device, including at-home exercises and clinic visits

12 weeks

Weekly visits (in-person), daily at-home exercises

Follow-up

Participants are monitored for rehabilitation outcomes and complete assessments at 3-month, 6-month, and discharge visits

6 months

3 visits (in-person)

Treatment Details

Interventions

• BAND Connect's VirtuaCare™ platform

Trial Overview The study tests the BAND Connect's VirtuaCare™ platform against standard care in physical therapy adherence post-surgery. The VirtuaCare™ provides instructions and real-time biofeedback to help patients perform their exercises correctly at home.

Participant Groups

Group I: Group 1 Experimental Treatment 1 Intervention

Group 1 will be using the BAND CVCP both in the clinic and at home to supplement the treatment protocols used in the clinic today.

Group II: Group 2 Placebo Group 1 Intervention

Group 2 will receive standard-of-care physical therapy without the use of the BAND CVCP.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+