Clinical trial NCT05080894: Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction
Official title: Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Keywords: virtual reality
embodiment
rehabilitation
anterior cruciate ligament reconstruction
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2021-10-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: Baseline (day 1 post-surgery)
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 4 weeks
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 12 weeks
measure: The International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 9 months
Secondary outcomes:
measure: Isometric quadriceps strength
timeFrame: Baseline
measure: Isometric quadriceps strength
timeFrame: 4 weeks
measure: Isometric quadriceps strength
timeFrame: 12 weeks
measure: Isometric quadriceps strength
timeFrame: 9 months
measure: Knee extension active range of motion
timeFrame: Baseline
measure: Knee extension active range of motion
timeFrame: 4 weeks
measure: Knee extension active range of motion
timeFrame: 12 weeks
measure: Knee extension active range of motion
timeFrame: 9 months
measure: Time taken to return to sporting activity
timeFrame: 9 months
measure: Kinesiophobia
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: 4 weeks
measure: Kinesiophobia
timeFrame: 12 weeks
measure: Kinesiophobia
timeFrame: 9 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIBAPS
Study officials:
affiliation: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Maria V. Sanchez-Vives
role: PRINCIPAL_INVESTIGATOR
References: