Telerehabilitation for Shoulder Surgery Recovery
1 other identifier
interventional
68
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 6, 2026
January 1, 2026
2.8 years
January 30, 2026
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Month 6
Secondary Outcomes (4)
Change in Visual Analogue Scale (VAS) Pain Score
Baseline, Month 6
Change in PROMIS Upper Extremity - Short Form 7a Score
Baseline, Month 6
Change in Days Per Week of Physical Therapy
Baseline, Month 6
Change in Intensity of Physical Therapy
Baseline, Month 6
Study Arms (2)
Control
ACTIVE COMPARATORIndividuals in the control arm will complete standard physical therapy sessions.
Band Connect Intervention
EXPERIMENTALIndividuals 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.
Interventions
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.
Standard physical therapy exercises for rotator cuff surgery rehabilitation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Kwon, MD, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2026
First Posted
February 6, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 5 years following article publication.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to young.kwon@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.