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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tears; Anatomic Total Shoulder Arthroplasty; Reverse Total Shoulder Arthroplasty

• Registration Number: NCT06733480
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 499

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Up to 6 months	This will be asked as a Yes/No question
Time to return to work measured in weeks	Up to 6 months
Number of patients who returned to sports	Up to 6 months	This will be asked as a Yes/No question
Change in pain as measured by the Visual Analog Scale	Baseline, 1 month, 3 months, 6 months	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').
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	Up to 6 months	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
Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score	Up to 6 months	Scored out of 100, with higher scores indicating greater satisfaction
Number of adverse events as measured by medical record review.	Up to 6 months

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States