An interventional study of Virtual reality in Knee Injuries, sponsored by Institut d'Investigacions Biomèdiques August Pi i Sunyer. Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Institut d'Investigacions Biomèdiques August Pi i Sunyer · Not applicable, Interventional, and Treatment
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.
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.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Institut d'Investigacions Biomèdiques August Pi i Sunyer is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol
Device: Virtual reality
Standard rehabilitation protocol only
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.
The International Knee Documentation Committee (IKDC) Subjective Knee Form
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).
Time frame: Baseline (day 1 post-surgery)
The International Knee Documentation Committee (IKDC) Subjective Knee Form
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).
Time frame: 4 weeks
The International Knee Documentation Committee (IKDC) Subjective Knee Form
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).
Time frame: 12 weeks
The International Knee Documentation Committee (IKDC) Subjective Knee Form
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).
Time frame: 9 months
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time frame: Baseline
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time frame: 4 weeks
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time frame: 12 weeks
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time frame: 9 months
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Time frame: Baseline
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Time frame: 4 weeks
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Time frame: 12 weeks
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Time frame: 9 months
Time taken to return to sporting activity
Taken retrospectively at 9 months, number of days from surgery to full return to sport
Time frame: 9 months
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Time frame: Baseline
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Time frame: 4 weeks
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Time frame: 12 weeks
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Time frame: 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Institut d'Investigacions Biomèdiques August Pi i Sunyer