Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

NCT ID: NCT05080894

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-12-15

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.

Conditions

Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual reality

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: DEVICE

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.

Standard intervention

Standard rehabilitation protocol only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Mutua Madrileña

OTHER

Sponsor Role: collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: lead

Responsible Party

Prof. Maria V. Sanchez-Vives

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria V. Sanchez-Vives

Role: PRINCIPAL_INVESTIGATOR

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Locations

IDIBAPS

Barcelona, , Spain

Countries

Spain

Other Identifiers

HCB-2019-0670

Identifier Type: -

Identifier Source: org_study_id