Telerehabilitation for Shoulder Surgery Recovery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Behavioral: Physical Therapy; Device: Band Connect

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Kwon, MD, PhD; Phone Number: 646-501-7223; Email: Young.kwon@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Individuals in the control arm will complete standard physical therapy sessions.	Behavioral: Physical Therapy; Standard physical therapy exercises for rotator cuff surgery rehabilitation.
Experimental: Band Connect Intervention; 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.	Behavioral: Physical Therapy; Standard physical therapy exercises for rotator cuff surgery rehabilitation.; Device: Band Connect; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Month 6
Change in Days Per Week of Physical Therapy	Number of days per week physical therapy exercises were completed at home.	Baseline, Month 6
Change in Intensity of Physical Therapy	Participants rank the intensity on a scale from 0 (not intense) to 10 (intenst).	Baseline, Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Young Kwon, MD, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: 25-01417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes