Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.

Study Overview

• Status: Completed
• Conditions: Knee Injuries
• Intervention / Treatment: Device: Virtual reality

Detailed Description

After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria V. Sanchez-Vives, PhD; Phone Number: 4379/4302 93 227 5400; Email: msanche3@clinic.cat
• Study Contact Backup: Name: Tony G Donegan, MSc; Phone Number: 4379/4302 93 227 5400; Email: donegan@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • IDIBAPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18-40 (either sex)
• Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft

Exclusion Criteria:

• Patients with significant cognitive deficit (MEC<24).
• Patients with epilepsy or severe vision problems
• Pregnant patients
• Previous surgery on the reconstructed knee, excluding arthroscopy
• Previous anterior cruciate ligament reconstruction on either knee
• Sustained concurrent injury to the contralateral knee
• Concomitant collateral ligament and/or meniscal repair
• Presence of symptomatic tibiofemoral osteoarthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality; Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol	Device: Virtual reality; Embodiment of a healthy virtual body in virtual reality and action observation/motor imagery of the subject's virtual body performing high-level lower limb exercises.
No Intervention: Standard intervention; Standard rehabilitation protocol only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The International Knee Documentation Committee (IKDC) Subjective Knee Form	Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. 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).	Baseline (day 1 post-surgery)
The International Knee Documentation Committee (IKDC) Subjective Knee Form	Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. 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).	4 weeks
The International Knee Documentation Committee (IKDC) Subjective Knee Form	Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. 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).	12 weeks
The International Knee Documentation Committee (IKDC) Subjective Knee Form	Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. 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).	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	Baseline
Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	4 weeks
Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	12 weeks
Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	9 months
Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	Baseline
Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	4 weeks
Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	12 weeks
Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	9 months
Time taken to return to sporting activity	Taken retrospectively at 9 months, number of days from surgery to full return to sport	9 months
Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	Baseline
Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	4 weeks
Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	12 weeks
Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	9 months

Collaborators and Investigators

• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Collaborators: Fundación Mutua Madrileña
• Investigators: Principal Investigator: Maria V. Sanchez-Vives, Institut d'Investigacions Biomèdiques August Pi i Sunyer

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality; anterior cruciate ligament reconstruction; embodiment
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: HCB-2019-0670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No