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Completed

NCT Number: NCT05080894

Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDIBAPS

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

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.

Primary outcomes

  1. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: Baseline (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).

  2. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 4 weeks

    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).

  3. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 12 weeks

    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).

  4. The International Knee Documentation Committee (IKDC) Subjective Knee Form

    Time frame: 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 outcomes

  1. Isometric quadriceps strength

    Time frame: Baseline

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

  2. Isometric quadriceps strength

    Time frame: 4 weeks

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

  3. Isometric quadriceps strength

    Time frame: 12 weeks

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

  4. Isometric quadriceps strength

    Time frame: 9 months

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

  5. Knee extension active range of motion

    Time frame: Baseline

    Measured with a digital goniometer (smartphone app)

  6. Knee extension active range of motion

    Time frame: 4 weeks

    Measured with a digital goniometer (smartphone app)

  7. Knee extension active range of motion

    Time frame: 12 weeks

    Measured with a digital goniometer (smartphone app)

  8. Knee extension active range of motion

    Time frame: 9 months

    Measured with a digital goniometer (smartphone app)

  9. Time taken to return to sporting activity

    Time frame: 9 months

    Taken retrospectively at 9 months, number of days from surgery to full return to sport

  10. Kinesiophobia

    Time frame: Baseline

    Fear of movement as measured with the Tampa scale of kinesiophobia

  11. Kinesiophobia

    Time frame: 4 weeks

    Fear of movement as measured with the Tampa scale of kinesiophobia

  12. Kinesiophobia

    Time frame: 12 weeks

    Fear of movement as measured with the Tampa scale of kinesiophobia

  13. Kinesiophobia

    Time frame: 9 months

    Fear of movement as measured with the Tampa scale of kinesiophobia

Sponsors and collaborators

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Other

Collaborators

  • Fundación Mutua Madrileña

Registry information

Official study title

Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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