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NCT Number: NCT06733480

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.

Recruiting

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Key information

Conditions

Rotator Cuff Tears Anatomic Total Shoulder Arthroplasty Reverse Total Shoulder Arthroplasty Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Kira Smith, MD

CONTACT

[email protected]

216-844-3233

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of physical therapy visits as measured by medical record review.

    Time frame: Up to 6 months

  2. Number of home exercise programs completed as measured by medical record review.

    Time frame: Up to 6 months

  3. Number of in clinic visits as measured by medical record review.

    Time frame: Up to 6 months

  4. Number of patients who were able to return to work

    Time frame: Up to 6 months

    This will be asked as a Yes/No question

  5. Time to return to work measured in weeks

    Time frame: Up to 6 months

  6. Number of patients who returned to sports

    Time frame: Up to 6 months

    This will be asked as a Yes/No question

  7. Change in pain as measured by the Visual Analog Scale

    Time frame: 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').

  8. Active range of motion measured in degrees

    Time frame: Up to 6 months

  9. Passive range of motion measured in degrees

    Time frame: Up to 6 months

  10. Strength will be measured on a scale of 0-5

    Time frame: 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

  11. Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score

    Time frame: Up to 6 months

    Scored out of 100, with higher scores indicating greater satisfaction

  12. Number of adverse events as measured by medical record review.

    Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kira Smith, MD

CONTACT

[email protected]

216-844-3233

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Band Connect

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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