Increased Home-based Physical Therapy Adherence Using BAND Connect's VirtuaCare™ Platform

April 28, 2026 updated by: Brian Grawe, University of Cincinnati

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the effectiveness of the BAND CVCP device with the standard physical therapy regimens provided by UC Health Orthopaedic Surgery. Participants undergoing shoulder surgeries performed by Dr. Brian Grawe will be randomly assigned to one of two groups. Group 1 will utilize the BAND CVCP both in the clinic and at home as a supplement to their treatment protocols. Group 2 will receive standard physical therapy without the BAND CVCP.

In Group 1, participants will be given access to the BAND CVCP and necessary materials during their first physical therapy appointment. The physical therapist will guide them through exercises using the device, recording their actions and providing real-time feedback. The BAND CVCP app on their provided Android phone will offer instructions for each exercise, eliminating the need to memorize the routine.

During clinic visits, Group 1 participants' progress will be reviewed using the BAND CVCP participant report. The report will display information such as completed exercises, form, pace, range of motion, and exertion, which is measured by sensors in the BAND CVCP handles. The therapist will help participants understand any corrections needed for their at-home exercises and make adjustments to their rehabilitation plan accordingly.

Both Group 1 and Group 2 participants will complete patient report outcomes at different intervals, including pre-operative scores, weekly visual analog scale assessments, and monthly assessments such as the Upper Extremity Functional Index (UEFI) or Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH). Group 1 participants will complete these forms using the BAND CVCP's phone application, while Group 2 participants will use paper copies at the clinic.

Additional assessments will be conducted at the 3-month, 6-month, and discharge from care visits, which include the ASES, SST, and EQ-5D-5L forms. Group 1 participants will complete these assessments on the BAND CVCP's phone application, while Group 2 participants will use paper copies at the clinic.

This study aims to evaluate the effectiveness of the BAND CVCP device compared to standard physical therapy regimens and track participant rehabilitation outcomes throughout the process.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Brian M Grawe, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
Placebo Comparator: Group 2
Group 2 will receive standard-of-care physical therapy without the use of the BAND CVCP.
Other: Standard of Care Physical Therapy
Standard of care physical therapy without the use of the BAND CVCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Visits
Time Frame: 12 weeks
Number of visits with physical therapist
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: Brian M Grawe, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM22053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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