NCT04541940

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

First Submitted

Initial submission to the registry

September 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

September 2, 2020

Last Update Submit

June 29, 2022

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

  • RTS (Return to Sport)

    The day when the participant is able to fully participate in their sport, but not at their desired performance level.

    up to 1 year post-op

Secondary Outcomes (4)

  • ACL-RSI Questionnaire Score

    up to 1 year post-op

  • Visual Analogue Scale (VAS) Score

    up to 1 year post-op

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    up to 1 year post-op

  • International Knee Documentation Committee (IKDC) Score

    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 - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.

Telerehabilitation
In-person Rehabilitation TherapyOTHER

Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.

In-Person Rehabilitation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Scheduled for ACL reconstruction
  • Age 18-40
  • Ability to comply with a standardized postoperative protocol
  • Willing and able to provide consent

You may not qualify if:

  • Pregnant patient
  • Age \>40 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

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Kirk Campbell, MD

    kirk.campbell@nyulangone.org

    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

September 2, 2020

First Posted

September 9, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

November 30, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

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
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.

Locations

US(1)