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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: July 1, 2024

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.

Interventions

• 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.
• Other: Standard of Care Physical Therapy
  • Standard of care physical therapy without the use of the BAND CVCP

Arms, Groups and Cohorts

• 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.

Clinical Trial Outcome Measures

Primary Measures

• Number of Visits
  • Time Frame: 12 weeks
  • Number of visits with physical therapist

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Cincinnati
• Provider of Information About this Clinical Study
  • Principal Investigator: Brian Grawe, Principal Investigator – University of Cincinnati
• Overall Official(s)
  • Brian M Grawe, MD, Principal Investigator, University of Cincinnati
• Overall Contact(s)
  • Kim Hasselfeld, 513-558-1933, hasselky@uc.edu

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