TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
Primary Purpose
Rotator Cuff Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation Therapy
In-person Rehabilitation Therapy
Sponsored by
About this trial
This is an interventional other trial for Rotator Cuff Injuries
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Telerehabilitation
In-Person Rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
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°.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04541953
Brief Title
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
Official Title
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation
Arm Type
Active Comparator
Arm Title
In-Person Rehabilitation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
In-person Rehabilitation Therapy
Intervention Description
Range of motion exercises and stretching
Primary Outcome Measure Information:
Title
Level of Range of Motion
Description
Active and passive range of motions will be tested in participants: forward flexion, abduction and internal/external rotation at 0° and 90°.
Time Frame
up to 1 year post-op
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Score
Description
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.
Time Frame
up to 1 year post-op
Title
American Shoulder and Elbow Surgeons (ASES) Questionnaire Score
Description
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.
Time Frame
up to 1 year post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk Campbell, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
We'll reach out to this number within 24 hrs