NCT04644640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

November 20, 2020

Last Update Submit

May 2, 2023

Conditions

Meniscectomy

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to 1 year post-op

  • 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).

    up to 1 year post-op

Study Arms (2)

Telerehabilitation

ACTIVE COMPARATOR
Other: Telerehabilitation Therapy

In-Person Rehabilitation

ACTIVE COMPARATOR
Other: In-person Rehabilitation Therapy

Interventions

Telerehabilitation TherapyOTHER

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

Telerehabilitation
In-person Rehabilitation TherapyOTHER

Range of motion exercises for the knee, proprioception and balance training

In-Person Rehabilitation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for meniscectomy
  • Age 18-75
  • Ability to comply with a standardized postoperative protocol
  • Willing and able to provide consent

You may not qualify if:

  • Pregnant patient
  • Age \>75 years, or \< 18
  • Previous knee surgery
  • Unable to speak English or perform informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Kirk Campbell, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 25, 2020

Study Start

November 11, 2020

Primary Completion

August 30, 2021

Study Completion

April 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
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 will have access to 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.

Locations

US(1)