TeleRehabilitation Following ACL Reconstruction

ACL Injury Clinical Trial

Official title:

TeleRehabilitation Following ACL Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541940
• Other study ID #: 20-01260
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: June 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

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.
• In-person Rehabilitation Therapy
Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ACL-RSI Questionnaire Score	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.	up to 1 year post-op
Secondary	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
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.	up to 1 year post-op
Secondary	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