NCT05080894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

2.1 years

First QC Date

September 20, 2021

Last Update Submit

April 16, 2024

Conditions

Knee Injuries

Keywords

virtual realityembodimentrehabilitationanterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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

  • 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

  • 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 Outcomes (13)

  • Isometric quadriceps strength

    Baseline

  • Isometric quadriceps strength

    4 weeks

  • Isometric quadriceps strength

    12 weeks

  • Isometric quadriceps strength

    9 months

  • Knee extension active range of motion

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

Virtual reality

EXPERIMENTAL

Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol

Device: Virtual reality

Standard intervention

NO INTERVENTION

Standard rehabilitation protocol only

Interventions

Virtual realityDEVICE

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.

Virtual reality

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-40 (either sex)
  • Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIBAPS

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Maria V. Sanchez-Vives

    Institut d'Investigacions Biomèdiques August Pi i Sunyer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 18, 2021

Study Start

October 1, 2021

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)