Rotator Cuff InjuriesNCT07392502
Telerehabilitation for Shoulder Surgery Recovery
A study testing Band Connect and Physical Therapy in people with Rotator Cuff Injuries, run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of a telerehabilitation protocol utilizing the Band Connect platform in patient recovery following rotator cuff repair surgery. This will be a randomized control trial with patients assigned into a traditional rehabilitation or a telerehabilitation protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Band Connect and Physical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Scheduled for primary arthroscopic rotator cuff repair Surgery to be performed by Dr. Young Kwon, Dr. Mandeep Virk, Dr. Dennis DeBernardis, or Dr. Jie Yao
- Planning to complete postoperative physical therapy at selected NYU physical therapy locations
- Access to home internet and a wireless cell phone compatible with the Band Connect App
Who cannot join
- Patients undergoing revision RCR
- Patients whose post operative rehabilitation has to be delayed or modified.
- Pregnant individuals
- Shoulder injuries related to workers compensation or involved in any pending litigation
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Telerehabilitation for Shoulder Surgery Recovery: A Randomized Trial Assessing the Effectiveness of the Band Connect Platform
This study aims to evaluate the effectiveness of a telerehabilitation protocol utilizing the Band Connect platform in patient recovery following rotator cuff repair surgery. This will be a randomized control trial with patients assigned into a traditional rehabilitation or a telerehabilitation protocol.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Band Connect, 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
The Band Connect device has two main components: smart handles and resistance bands in varying lengths and resistance. The smart handles transfer data back to a phone app, which provides the patient instructions for their prescribed treatment as well as simulated biofeedback to ensure appropriate technique. The sensor function of Band Connect allows physical therapists to track participant movements to assess physical therapy activity. No video is being recorded of the participant.
Physical TherapyBehavioural
Standard physical therapy exercises for rotator cuff surgery rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Individuals in the control arm will complete standard physical therapy sessions. Receives: Behavioral: Physical Therapy |
| Band Connect Intervention | Experimental | Individuals in the experimental arm will complete standard physical therapy sessions while using the Band Connect device, which allows for direct measurement of patient force generated as well as positioning during the completion of physical therapy exercises. Receives: Device: Band Connect; Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Shoulder and Elbow Surgeons (ASES)
The ASES is a 17-item questionnaire measuring shoulder pain and function. The total score is standardized into a 0-100 scale; higher scores indicate less pain/greater function.
Measured: Baseline, Month 6
Secondary outcomes (4)
Change in Visual Analogue Scale (VAS) Pain Score
Pain is rated on a scale from 0-100; higher scores indicate greater pain. Participants rate pain specific to the shoulder that was operated on.
Measured: Baseline, Month 6
Change in PROMIS Upper Extremity - Short Form 7a Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity - Short Form 7a comprises 7 questions assessing functionality of upper extremities. The raw score is standardized to a total score from 0-100 with a mean of 50 and standard deviation of 10. Higher scores indicate greater functionality of upper extremities.
Measured: Baseline, Month 6
Change in Days Per Week of Physical Therapy
Number of days per week physical therapy exercises were completed at home.
Measured: Baseline, Month 6
Change in Intensity of Physical Therapy
Participants rank the intensity on a scale from 0 (not intense) to 10 (intenst).
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Kwon, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392502
- Sponsor's protocol ID
- 25-01417
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 3 months to 5 years after publication, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: young.kwon@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation for Shoulder Surgery Recovery: A Randomized Trial Assessing the Effectiveness of the Band Connect Platform
- ClinicalTrials.gov ID
- NCT07392502
- Acronym / sponsor ID
- 25-01417
- Conditions
- Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 2026 (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.
This study aims to evaluate the effectiveness of a telerehabilitation protocol utilizing the Band Connect platform in patient recovery following rotator cuff repair surgery. This will be a randomized control trial with patients assigned into a traditional rehabilitation or a telerehabilitation protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Physical TherapyIndividuals in the control arm will complete standard physical therapy sessions. |
| Band Connect Intervention | Experimental | Device: Band Connect, Behavioral: Physical TherapyIndividuals in the experimental arm will complete standard physical therapy sessions while using the Band Connect device, which allows for direct measurement of patient force generated as well as positioning during the completion of physical therapy exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Scheduled for primary arthroscopic rotator cuff repair Surgery to be performed by Dr. Young Kwon, Dr. Mandeep Virk, Dr. Dennis DeBernardis, or Dr. Jie Yao
- Planning to complete postoperative physical therapy at selected NYU physical therapy locations
- Access to home internet and a wireless cell phone compatible with the Band Connect App
Key exclusion criteria (5 listed)
- Patients undergoing revision RCR
- Patients whose post operative rehabilitation has to be delayed or modified.
- Pregnant individuals
- Shoulder injuries related to workers compensation or involved in any pending litigation
- Patients unable to provide informed consent
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 ConnectThe Band Connect device has two main components: smart handles and resistance bands in varying lengths and resistance. The smart handles transfer data back to a phone app, which provides the patient instructions for their prescribed treatment as well as simulated biofeedback to ensure appropriate technique. The sensor function of Band Connect allows physical therapists to track participant movements to assess physical therapy activity. No video is being recorded of the participant. | Device | Band Connect Intervention |
| Physical TherapyStandard physical therapy exercises for rotator cuff surgery rehabilitation. | Behavioural | Band Connect Intervention, Control |
Primary outcome
Change in American Shoulder and Elbow Surgeons (ASES)
Time frame: Baseline, Month 6
The ASES is a 17-item questionnaire measuring shoulder pain and function. The total score is standardized into a 0-100 scale; higher scores indicate less pain/greater function.
4 secondary outcomes
Change in Visual Analogue Scale (VAS) Pain Score
Time frame: Baseline, Month 6
Change in PROMIS Upper Extremity - Short Form 7a Score
Time frame: Baseline, Month 6
Change in Days Per Week of Physical Therapy
Time frame: Baseline, Month 6
Change in Intensity of Physical Therapy
Time frame: Baseline, Month 6
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 Feb 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 3 months to 5 years after publication, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: young.kwon@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Rotator Cuff Injuries
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
Young Kwon, MD, PhD principal investigator
NYU Langone Health
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 and Physical Therapy in people with Rotator Cuff Injuries, run by NYU Langone Health 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Feb 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 Young Kwon, MD, PhD (646-501-7223, Young.kwon@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in American Shoulder and Elbow Surgeons (ASES) (time frame: Baseline, Month 6). 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 Feb 2026.