Recruiting

Physical Therapy

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06733480

Conditions

Rotator Cuff Tears

Anatomic Total Shoulder Arthroplasty

Reverse Total Shoulder Arthroplasty

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Band Connect

Study Details

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

Study ID

NCT06733480

Start date

Feb 4, 2025

Status verified date

Jul, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

499 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Number of physical therapy visits as measured by medical record review. [ Time Frame: Up to 6 months ]
  • Number of home exercise programs completed as measured by medical record review. [ Time Frame: Up to 6 months ]
  • Number of in clinic visits as measured by medical record review. [ Time Frame: Up to 6 months ]
  • Number of patients who were able to return to work [ Time Frame: Up to 6 months ]
  • Time to return to work measured in weeks [ Time Frame: Up to 6 months ]
  • Number of patients who returned to sports [ Time Frame: Up to 6 months ]
  • Change in pain as measured by the Visual Analog Scale [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
  • Active range of motion measured in degrees [ Time Frame: Up to 6 months ]
  • Passive range of motion measured in degrees [ Time Frame: Up to 6 months ]
  • Strength will be measured on a scale of 0-5 [ Time Frame: Up to 6 months ]
  • Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score [ Time Frame: Up to 6 months ]
  • Number of adverse events as measured by medical record review. [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Kira Smith, MD

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

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kira Smith, MD

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

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • physical therapy compliance
  • home-based physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-07-06.