TeleRehabilitation Following Arthroscopic Rotator Cuff Repair

NCT04541953 | Completed

• 1 other identifier: 20-01261
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analogue Scale (VAS) Score

  up to 1 year post-op

• American Shoulder and Elbow Surgeons (ASES) Questionnaire Score

  up to 1 year post-op

Study Arms (2)

Telerehabilitation

ACTIVE COMPARATOR

Other: Telerehabilitation Therapy

In-Person Rehabilitation

ACTIVE COMPARATOR

Other: In-person Rehabilitation Therapy

Interventions

Telerehabilitation Therapy OTHER

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.

Telerehabilitation

In-person Rehabilitation Therapy OTHER

Range of motion exercises and stretching

In-Person Rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Kirk Campbell, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: September 16, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)