Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080894
• Other study ID #: HCB-2019-0670
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2024
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	IDIBAPS	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (day 1 post-surgery)
Primary	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).	4 weeks
Primary	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).	12 weeks
Primary	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).	9 months
Secondary	Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	Baseline
Secondary	Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	4 weeks
Secondary	Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	12 weeks
Secondary	Isometric quadriceps strength	Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)	9 months
Secondary	Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	Baseline
Secondary	Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	4 weeks
Secondary	Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	12 weeks
Secondary	Knee extension active range of motion	Measured with a digital goniometer (smartphone app)	9 months
Secondary	Time taken to return to sporting activity	Taken retrospectively at 9 months, number of days from surgery to full return to sport	9 months
Secondary	Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	Baseline
Secondary	Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	4 weeks
Secondary	Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	12 weeks
Secondary	Kinesiophobia	Fear of movement as measured with the Tampa scale of kinesiophobia	9 months