Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

Not Applicable

Completed

• Conditions: Knee Injuries
• Interventions: Device: Virtual reality

• Registration Number: NCT05080894
• Lead Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-09-20
• Study Start: 2021-10-01
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-18
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	Virtual reality	Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol

Primary Outcome Measures

Name	Time	Method
The International Knee Documentation Committee (IKDC) Subjective Knee Form	9 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IDIBAPS; 🇪🇸 Barcelona, Spain