Rotator Cuff TearsNCT06733480
Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
A study testing Band Connect in people with Rotator Cuff Tears and Anatomic Total Shoulder Arthroplasty, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Rotator Cuff Tears, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
- What is being tested?
- Band Connect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Kira Smith, MD, 216-844-3233, kira.smith@uhhospitals.org
About this study
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
- Being tested
- Band Connect
- Keywords
- physical therapy compliance, home-based physical therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Band ConnectDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of physical therapy visits as measured by medical record review.
Measured: Up to 6 months
Number of home exercise programs completed as measured by medical record review.
Measured: Up to 6 months
Number of in clinic visits as measured by medical record review.
Measured: Up to 6 months
Number of patients who were able to return to work
This will be asked as a Yes/No question
Measured: Up to 6 months
Time to return to work measured in weeks
Measured: Up to 6 months
Number of patients who returned to sports
This will be asked as a Yes/No question
Measured: 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').
Measured: Baseline, 1 month, 3 months, 6 months
Active range of motion measured in degrees
Measured: Up to 6 months
Passive range of motion measured in degrees
Measured: 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
Measured: 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
Measured: Up to 6 months
Number of adverse events as measured by medical record review.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Feb 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 499 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Band Connect
- Responsible party
- Principal investigator, Robert J. Gillespie, University Hospitals Cleveland Medical Center
- Investigators
- Robert Gillespie, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733480
- Sponsor's protocol ID
- STUDY20241277
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
- ClinicalTrials.gov ID
- NCT06733480
- Acronym / sponsor ID
- STUDY20241277
- Conditions
- Rotator Cuff Tears, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
- Keywords
- physical therapy compliance, home-based physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 499 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Band Connect
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Band Connect | Experimental | Device: Band ConnectPatients in group 1 will be set up with the Band Connect platform and build their treatment plan at the first in-clinic visit. |
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Band ConnectBand 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. | Device | Group 1 Band Connect |
Primary outcome
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
This will be asked as a Yes/No question
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
This will be asked as a Yes/No question
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').
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
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
Time frame: Up to 6 months
Scored out of 100, with higher scores indicating greater satisfaction
Number of adverse events as measured by medical record review.
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Gillespie principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Band Connect in people with Rotator Cuff Tears and Anatomic Total Shoulder Arthroplasty, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kira Smith, MD (216-844-3233, kira.smith@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of physical therapy visits as measured by medical record review. (time frame: Up to 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.