TeleRehabilitation Following Arthroscopic Rotator Cuff Repair

Not Applicable

Completed

• Conditions: Rotator Cuff Injuries
• Interventions: Other: Telerehabilitation Therapy; Other: In-person Rehabilitation Therapy

• Registration Number: NCT04541953
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2020-09-16
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	Telerehabilitation Therapy	-
In-Person Rehabilitation	In-person Rehabilitation Therapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Score	up to 1 year post-op	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.
American Shoulder and Elbow Surgeons (ASES) Questionnaire Score	up to 1 year post-op	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States