TeleRehabilitation Following ACL Reconstruction

Not Applicable

Completed

• Conditions: ACL Injury
• Interventions: Other: In-person Rehabilitation Therapy; Other: Telerehabilitation Therapy

• Registration Number: NCT04541940
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2020-10-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-11-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Person Rehabilitation	In-person Rehabilitation Therapy	-
Telerehabilitation	Telerehabilitation Therapy	-

Primary Outcome Measures

Name	Time	Method
RTS (Return to Sport)	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

Name	Time	Method
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.
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).
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.
ACL-RSI Questionnaire Score	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.

Trial Locations

Locations (1)

NYU Langone; 🇺🇸 New York, New York, United States