NCT05080894 - Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction | Crick

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

44

Conditions

Knee Injuries

Interventions

Virtual realityDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

IDIBAPS

Barcelona, Spain

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 9 months

Secondary Outcomes

Isometric quadriceps strength

Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)

Time frame: Baseline

Isometric quadriceps strength