TeleRehabilitation Following Arthroscopic Rotator Cuff Repair

Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the research study is to compare two standard of care rehabilitation methods (telerehabilitation vs in-person rehabilitation) following routine rotator cuff repair. Objectives include assessing range of motion and patient reported functional outcomes.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Other: Telerehabilitation Therapy; Other: In-person Rehabilitation Therapy

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to undergo Rotator Cuff repair
• Age 40-80
• Ability to comply with a standardized postoperative protocol
• Willing and able to provide consent

Exclusion Criteria:

• Pregnant patient
• Age <40 years
• Previous shoulder surgery
• Unable to speak English or perform informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telerehabilitation	Other: Telerehabilitation Therapy; Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - range of motion exercises and stretching.
Active Comparator: In-Person Rehabilitation	Other: In-person Rehabilitation Therapy; Range of motion exercises and stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Range of Motion	Active and passive range of motions will be tested in participants: forward flexion, abduction and internal/external rotation at 0° and 90°.	up to 1 year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Score	VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The total score ranges from 0-10. The higher the score, the worse the pain.	up to 1 year post-op
American Shoulder and Elbow Surgeons (ASES) Questionnaire Score	The ASES score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions will be used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. The final pain score (maximum 50 points) is calculated by subtracting the VAS from 10 and multiplying by five. For the functional portion, each of 10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 points. The raw score is multiplied by 5/3 to make the maximal functional score out of 50 possible points. The pain and functional portions are then summed to obtain the final ASES score. The higher the score, the worse the pain and level of function.	up to 1 year post-op

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kirk Campbell, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 20-01261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Data will be shared beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to kirk.campbell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No