TeleRehabilitation Following Arthroscopic Rotator Cuff Repair

Rotator Cuff Injuries Clinical Trial

Official title:

TeleRehabilitation Following Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541953
• Other study ID #: 20-01261
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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.
• In-person Rehabilitation Therapy
Range of motion exercises and stretching

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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