Skip to main content
Clinical Trials/NCT05080894
NCT05080894
Completed
Not Applicable

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

Institut d'Investigacions Biomèdiques August Pi i Sunyer1 site in 1 country44 target enrollmentOctober 1, 2021
ConditionsKnee Injuries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Injuries
Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Enrollment
44
Locations
1
Primary Endpoint
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Maria V. Sanchez-Vives

Professor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

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

Outcomes

Primary Outcomes

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

  • Time taken to return to sporting activity(9 months)
  • Isometric quadriceps strength(9 months)
  • Kinesiophobia(9 months)
  • Knee extension active range of motion(9 months)

Study Sites (1)

Loading locations...

Similar Trials