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

NCT05876208 | Recruiting

• 1 other identifier: SM22053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Rotator Cuff Repair; Anatomic and Reverse Total Shoulder

Outcome Measures

Primary Outcomes (1)

• Number of Visits

  Number of visits with physical therapist

  12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

PLACEBO COMPARATOR

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

Other: Standard of Care Physical Therapy

Interventions

BAND Connect's VirtuaCare™ platform OTHER

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.

Group 1

Standard of Care Physical Therapy OTHER

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Huberty DP, Schoolfield JD, Brady PC, Vadala AP, Arrigoni P, Burkhart SS. Incidence and treatment of postoperative stiffness following arthroscopic rotator cuff repair. Arthroscopy. 2009 Aug;25(8):880-90. doi: 10.1016/j.arthro.2009.01.018.

  PMID: 19664508 BACKGROUND

• Koo SS, Parsley BK, Burkhart SS, Schoolfield JD. Reduction of postoperative stiffness after arthroscopic rotator cuff repair: results of a customized physical therapy regimen based on risk factors for stiffness. Arthroscopy. 2011 Feb;27(2):155-60. doi: 10.1016/j.arthro.2010.07.007. Epub 2010 Oct 20.

  PMID: 20970299 BACKGROUND

• Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.

  PMID: 30441330 BACKGROUND

• Brandao AF, Dias DR, Castellano G, Parizotto NA, Trevelin LC. RehabGesture: An Alternative Tool for Measuring Human Movement. Telemed J E Health. 2016 Jul;22(7):584-9. doi: 10.1089/tmj.2015.0139. Epub 2016 May 12.

  PMID: 27172389 BACKGROUND

• Kennedy JS, Garrigues GE, Pozzi F, Zens MJ, Gaunt B, Phillips B, Bakshi A, Tate AR. The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation for anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2020 Oct;29(10):2149-2162. doi: 10.1016/j.jse.2020.05.019. Epub 2020 Jun 10.

  PMID: 32534209 BACKGROUND

• Brameier DT, Hirscht A, Kowalsky MS, Sethi PM. Rehabilitation Strategies After Shoulder Arthroplasty in Young and Active Patients. Clin Sports Med. 2018 Oct;37(4):569-583. doi: 10.1016/j.csm.2018.05.007.

  PMID: 30201171 BACKGROUND

• Ikard ST Jr, Farmer KW, Struk AM, Garvan CS, Gillespy A, Wright TW. Rotator Cuff Dysfunction after Anatomic Total Shoulder Arthroplasty: Who is at Risk? J Surg Orthop Adv. 2020 Spring;29(1):31-35.

  PMID: 32223863 BACKGROUND

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Brian M Grawe, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Hasselfeld

CONTACT

513-558-1933; hasselky@uc.edu

Michael Kloby

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: July 5, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)