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OpenTrials
Completed

NCT Number: NCT04541953

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

In-person Rehabilitation Therapy

Other

Range of motion exercises and stretching

Primary outcomes

  1. Level of Range of Motion

    Time frame: 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 outcomes

  1. Visual Analogue Scale (VAS) Score

    Time frame: 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.

  2. American Shoulder and Elbow Surgeons (ASES) Questionnaire Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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