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

Official title

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

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.

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

Primary outcome measures

• Number of Visits [Time frame: 12 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Cincinnati — Cincinnati

Publications

• Cuff DJ, Pupello DR. Prospective randomized study of arthroscopic rotator cuff repair using an early versus delayed postoperative physical therapy protocol. J Shoulder Elbow Surg. 2012 Nov;21(11):1450-5. doi: 10.1016/j.jse.2012.01.025. Epub 2012 May 2. PMID 22554876
• Dahl-Popolizio S, Loman J, Cordes CC. Comparing Outcomes of Kinect Videogame-Based Occupational/Physical Therapy Versus Usual Care. Games Health J. 2014 Jun;3(3):157-61. doi: 10.1089/g4h.2014.0002. Epub 2014 Apr 17. PMID 26196174
• Keener JD, Galatz LM, Stobbs-Cucchi G, Patton R, Yamaguchi K. Rehabilitation following arthroscopic rotator cuff repair: a prospective randomized trial of immobilization compared with early motion. J Bone Joint Surg Am. 2014 Jan 1;96(1):11-9. doi: 10.2106/JBJS.M.00034. PMID 24382719
• Palazzo C, Klinger E, Dorner V, Kadri A, Thierry O, Boumenir Y, Martin W, Poiraudeau S, Ville I. Barriers to home-based exercise program adherence with chronic low back pain: Patient expectations regarding new technologies. Ann Phys Rehabil Med. 2016 Apr;59(2):107-13. doi: 10.1016/j.rehab.2016.01.009. Epub 2016 Apr 1. PMID 27050664
• Raaben M, Holtslag HR, Leenen LPH, Augustine R, Blokhuis TJ. Real-time visual biofeedback during weight bearing improves therapy compliance in patients following lower extremity fractures. Gait Posture. 2018 Jan;59:206-210. doi: 10.1016/j.gaitpost.2017.10.022. Epub 2017 Oct 20. PMID 29078134
• Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical therapy. Phys Ther. 1993 Nov;73(11):771-82; discussion 783-6. doi: 10.1093/ptj/73.11.771. PMID 8234458
• Arndt J, Clavert P, Mielcarek P, Bouchaib J, Meyer N, Kempf JF; French Society for Shoulder & Elbow (SOFEC). Immediate passive motion versus immobilization after endoscopic supraspinatus tendon repair: a prospective randomized study. Orthop Traumatol Surg Res. 2012 Oct;98(6 Suppl):S131-8. doi: 10.1016/j.otsr.2012.05.003. Epub 2012 Sep 1. PMID 22944392
• Denard PJ, Ladermann A, Burkhart SS. Prevention and management of stiffness after arthroscopic rotator cuff repair: systematic review and implications for rotator cuff healing. Arthroscopy. 2011 Jun;27(6):842-8. doi: 10.1016/j.arthro.2011.01.013. PMID 21624680

Identifiers

NCT: NCT05876208 · SM22053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗