Rotator Cuff Injuries
Conditions
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.
Interventions
DEVICEBand 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.
BEHAVIORALPhysical Therapy
Standard physical therapy exercises for rotator cuff surgery rehabilitation.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in American Shoulder and Elbow Surgeons (ASES) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) Pain Score | Baseline, Month 6 | 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. |
| Change in PROMIS Upper Extremity - Short Form 7a Score | Baseline, Month 6 | 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. |
| Change in Days Per Week of Physical Therapy | Baseline, Month 6 | Number of days per week physical therapy exercises were completed at home. |
| Change in Intensity of Physical Therapy | Baseline, Month 6 | Participants rank the intensity on a scale from 0 (not intense) to 10 (intenst). |
Countries
United States
Contacts
CONTACTYoung Kwon, MD, PhD
PRINCIPAL_INVESTIGATORYoung Kwon, MD, PhD
NYU Langone Health
Outcome results
None listed