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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05080894
Enrollment
44
Registered
2021-10-18
Start date
2021-10-01
Completion date
2023-12-15
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

Keywords

virtual reality, embodiment, rehabilitation, anterior cruciate ligament reconstruction

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.

Interventions

DEVICEVirtual 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.

Sponsors

Fundación Mutua Madrileña
CollaboratorOTHER
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The International Knee Documentation Committee (IKDC) Subjective Knee FormBaseline (day 1 post-surgery)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

MeasureTime frameDescription
Isometric quadriceps strengthBaselineMeasured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Knee extension active range of motionBaselineMeasured with a digital goniometer (smartphone app)
Time taken to return to sporting activity9 monthsTaken retrospectively at 9 months, number of days from surgery to full return to sport
KinesiophobiaBaselineFear of movement as measured with the Tampa scale of kinesiophobia

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026