Health Trials

Telerehabilitation for Shoulder Surgery Recovery

ConditionRotator Cuff Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Band Connect

    Device

    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 Therapy

    Behavioral

    Standard physical therapy exercises for rotator cuff surgery rehabilitation.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Band Connect InterventionExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Baseline, Month 6

Secondary outcomes

1

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.

Time frame
Baseline, Month 6
2

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.

Time frame
Baseline, Month 6
3

Change in Days Per Week of Physical Therapy

Number of days per week physical therapy exercises were completed at home.

Time frame
Baseline, Month 6
4

Change in Intensity of Physical Therapy

Participants rank the intensity on a scale from 0 (not intense) to 10 (intenst).

Time frame
Baseline, Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: