Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue

Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the procedure. The purpose of this research is to investigate the effectiveness of Band Connect, a connected health platform, in enhancing compliance with home exercise programs among patients undergoing physical therapy. This study aims to evaluate the implications of increased compliance on improving patient engagement and increasing satisfaction for both patients and clinicians. Additionally, the study will analyze the economic implications of implementing Band Connect's hybrid care model on driving increased revenue per patient.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears; Reverse Total Shoulder Arthroplasty; Anatomic Total Shoulder Arthroplasty
• Intervention / Treatment: Device: Band Connect

• Study Type: Interventional
• Enrollment (Estimated): 499
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kira Smith, MD; Phone Number: 216-844-3233; Email: kira.smith@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Kira Smith, MD; Phone Number: 216-844-3233; Email: kira.smith@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range: from 18 to 89 years old
• Surgery performed by Dr. Robert Gillespie and will be undergoing post-op physical therapy rehabilitation at University Hospitals
• Patients undergoing primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA)
• Patients undergoing primary rotator cuff repair
• Prescribed outpatient physical therapy for post-operative rehabilitation

Chart Review Inclusion Criteria:

• Age range: from 18 to 89 years old
• Surgery performed by Dr. Robert Gillespie who underwent post-op physical therapy rehabilitation at University Hospitals
• Patients who underwent primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA)
• Patients who underwent primary rotator cuff repair
• Prescribed outpatient physical therapy for post-operative rehabilitation

Exclusion Criteria:

• Patients undergoing hemiarthroplasty or revision TSA
• Patients undergoing revision rotator cuff repair
• TSA performed for proximal humerus fractures
• Length of stay in hospital following shoulder surgery greater than 3 days
• Shoulder injuries related to workers compensation or involved in any pending litigation
• Pregnant individuals

Chart Review Exclusion Criteria:

• Patients undergoing hemiarthroplasty or revision TSA
• Patients undergoing revision rotator cuff repair
• TSA performed for proximal humerus fractures
• Length of stay in hospital following shoulder surgery greater than 3 days
• Shoulder injuries related to workers compensation or involved in any pending litigation
• Pregnant individuals

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Band Connect; Patients in group 1 will be set up with the Band Connect platform and build their treatment plan at the first in-clinic visit.	Device: Band Connect; 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.
No Intervention: Group 2 Standard Care; Group 2 will consist of retrospective chart review to as act a control group. Charts will be pulled from 1/1/2019-12/31/2023.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of physical therapy visits as measured by medical record review.		Up to 6 months
Number of home exercise programs completed as measured by medical record review.		Up to 6 months
Number of in clinic visits as measured by medical record review.		Up to 6 months
Number of patients who were able to return to work	This will be asked as a Yes/No question	Up to 6 months
Time to return to work measured in weeks		Up to 6 months
Number of patients who returned to sports	This will be asked as a Yes/No question	Up to 6 months
Change in pain as measured by the Visual Analog Scale	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	Baseline, 1 month, 3 months, 6 months
Active range of motion measured in degrees		Up to 6 months
Passive range of motion measured in degrees		Up to 6 months
Strength will be measured on a scale of 0-5	Strength scale: 0: no visible or palpable contraction; 1: visible or palpable contraction without motion; 2: full range of motion, gravity eliminated; 3: full range of motion against gravity; 4: full range of motion against gravity, moderate resistance; 5: full range of motion against gravity, maximal resistance	Up to 6 months
Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score	Scored out of 100, with higher scores indicating greater satisfaction	Up to 6 months
Number of adverse events as measured by medical record review.		Up to 6 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Band Connect
• Investigators: Principal Investigator: Robert Gillespie, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: home-based physical therapy; physical therapy compliance
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: STUDY20241277

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: Yes
• product manufactured in and exported from the U.S.: No