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Telerehabilitation Following Meniscectomy

Sponsor
NYU Langone Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04644640
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
28.6
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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. Since telerehabilitation was found to be equally effective as conventional therapy, it was being practiced even before the COVID times, however it was truly valuable during the lockdown. 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 Meniscectomy.

Condition or Disease Intervention/Treatment Phase
  • Other: Telerehabilitation Therapy
  • Other: In-person Rehabilitation Therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Telerehabilitation Following Meniscectomy: A Randomized Clinical Trial
Actual Study Start Date :
Nov 11, 2020
Actual Primary Completion Date :
Aug 30, 2021
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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 - range of motion exercises for the knee, proprioception and balance training
Active Comparator: In-Person Rehabilitation

Other: In-person Rehabilitation Therapy
Range of motion exercises for the knee, proprioception and balance training

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) Score [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. International Knee Documentation Committee (IKDC) Score [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

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Scheduled for meniscectomy

  • Age 18-75

  • Ability to comply with a standardized postoperative protocol

  • Willing and able to provide consent

Exclusion Criteria:

  • Pregnant patient

  • Age >75 years, or < 18

  • Previous knee surgery

  • Unable to speak English or perform informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Kirk Campbell, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04644640
Other Study ID Numbers:
  • 20-01584
First Posted:
Nov 25, 2020
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 16, 2022