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Recruiting NCT06733480

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

No phase Interventional Rotator Cuff Tears Anatomic Total Shoulder Arthroplasty Reverse Total Shoulder Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Band Connect.
Who it may be relevant to
Registry conditions: Rotator Cuff Tears, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Hospitals Cleveland Medical Center — Cleveland

Identifiers

NCT: NCT06733480 · STUDY20241277

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗