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TeleRehabilitation Following ACL Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541940
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
ACL Injury Other: Telerehabilitation Therapy Other: In-person Rehabilitation Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: TeleRehabilitation Following ACL Reconstruction
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Telerehabilitation Other: Telerehabilitation Therapy
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.
Active Comparator: In-Person Rehabilitation Other: In-person Rehabilitation Therapy
Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.


Outcome Measures
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Primary Outcome Measures :
  1. RTS (Return to Sport) [ Time Frame: up to 1 year post-op ]
    The day when the participant is able to fully participate in their sport, but not at their desired performance level.


Secondary Outcome Measures :
  1. ACL-RSI Questionnaire Score [ Time Frame: up to 1 year post-op ]
    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.

  2. 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.

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: up to 1 year post-op ]
    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.

  4. International Knee Documentation Committee (IKDC) Score [ Time Frame: up to 1 year post-op ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541940


Contacts
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Contact: Kirk Campbell, MD 516-477-6064 kirk.campbell@nyulangone.org
Contact: Dhruv Shankar 240-848-8645 dhruv.shankar@nyulangone.org

Locations
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United States, New York
NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Dhruv Shankar    240-848-8645    dhruv.shankar@nyulangone.org   
Principal Investigator: Kirk Campbell, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Kirk Campbell, MD kirk.campbell@nyulangone.org
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04541940    
Other Study ID Numbers: 20-01260
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries