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Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

I

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Status

Completed

Conditions

Knee Injuries

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT05080894
HCB-2019-0670

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Virtual reality
Experimental group
Description:
Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol
Treatment:
Device: Virtual reality
Standard intervention
No Intervention group
Description:
Standard rehabilitation protocol only

Trial contacts and locations

1

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Central trial contact

Maria V. Sanchez-Vives, PhD; Tony G Donegan, MSc

Data sourced from clinicaltrials.gov

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