Recruiting

BAND Connect

Sponsor:

University of Cincinnati

Code:

NCT05876208

Conditions

Shoulder Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BAND Connect's VirtuaCare™ platform

Standard of Care Physical Therapy

Study Details

Brief summary:

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.

Conditions

Shoulder Injuries

Study ID

NCT05876208

Start date

Jul 5, 2022

Status verified date

Jul, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

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.

placebo comparator: Group 2

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

Interventions

BAND Connect's VirtuaCare™ platform

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.

Standard of Care Physical Therapy

Standard of care physical therapy without the use of the BAND CVCP

Primary outcome measure

  • Number of Visits [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kim Hasselfeld

513-558-1933hasselky@uc.edu

Michael Kloby

513-558-6077klobyml@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Kim Hasselfeld

5137776213hasselky@uc.edu

Michael Kloby

513-558-6077klobyml@ucmail.uc.edu

Principal Investigator:

Brian M Grawe, MD

More Information

Sponsor

University of Cincinnati

Last update posted

Apr 29, 2026

Last verified

Jul, 2025

Keywords

  • Rotator Cuff Repair
  • Anatomic and Reverse Total Shoulder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-04-29.