TeleRehabilitation Following ACL Reconstruction
Primary Purpose
ACL Injury
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 ACL Injury
Eligibility Criteria
Inclusion Criteria:
- Scheduled for ACL reconstruction
- Age 18-40
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Exclusion Criteria:
- Pregnant patient
- Age >40 years, or < 18
- Previous knee surgery
- Unable to speak English or perform informed consent
Sites / Locations
- NYU Langone
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
RTS (Return to Sport)
The day when the participant is able to fully participate in their sport, but not at their desired performance level.
Secondary Outcome Measures
ACL-RSI Questionnaire Score
ACL-RSI (anterior cruciate ligament - return to sport) consists of 12 questions. Each question is scored 0-100 with a total range of 0-1200. The higher the score, the more positive psychological outlook a participant has.
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a knee-specific instrument, developed to assess the participants' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales. Each subscale is calculated independently. The calculated mean score of the individual items of each subscale will be divided by 4. The total score range is 0-100. The lower the score, the more extreme the problems.
International Knee Documentation Committee (IKDC) Score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04541940
Brief Title
TeleRehabilitation Following ACL Reconstruction
Official Title
TeleRehabilitation Following ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 30, 2021 (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 proposed study is to evaluate telerehabilitation vs. in-person rehabilitation following ACL reconstruction. Objectives include assess return to sport and patient reported functional outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (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 - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
Intervention Type
Other
Intervention Name(s)
In-person Rehabilitation Therapy
Intervention Description
Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
Primary Outcome Measure Information:
Title
RTS (Return to Sport)
Description
The day when the participant is able to fully participate in their sport, but not at their desired performance level.
Time Frame
up to 1 year post-op
Secondary Outcome Measure Information:
Title
ACL-RSI Questionnaire Score
Description
ACL-RSI (anterior cruciate ligament - return to sport) consists of 12 questions. Each question is scored 0-100 with a total range of 0-1200. The higher the score, the more positive psychological outlook a participant has.
Time Frame
up to 1 year post-op
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
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
KOOS is a knee-specific instrument, developed to assess the participants' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales. Each subscale is calculated independently. The calculated mean score of the individual items of each subscale will be divided by 4. The total score range is 0-100. The lower the score, the more extreme the problems.
Time Frame
up to 1 year post-op
Title
International Knee Documentation Committee (IKDC) Score
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time Frame
up to 1 year post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for ACL reconstruction
Age 18-40
Ability to comply with a standardized postoperative protocol
Willing and able to provide consent
Exclusion Criteria:
Pregnant patient
Age >40 years, or < 18
Previous knee surgery
Unable to speak English or perform informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk Campbell, MD
Organizational Affiliation
kirk.campbell@nyulangone.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone
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 ACL Reconstruction
We'll reach out to this number within 24 hrs