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

NCT06733480 | Recruiting DMC FDA Device

• 1 other identifier: STUDY20241277
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Anatomic Total Shoulder Arthroplasty; Reverse Total Shoulder Arthroplasty

Keywords

physical therapy compliance; home-based physical therapy

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Group 1 Band Connect

EXPERIMENTAL

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

Group 2 Standard Care

NO INTERVENTION

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.

Interventions

Band Connect DEVICE

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 Band Connect

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Band Connect: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Robert Gillespie

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kira Smith, MD

CONTACT

216-844-3233; kira.smith@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Education

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)