Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06724679

VRFR- Immersive Virtual Reality Use in a Spine Functional Restoration Program - A Feasibility Study

Led by University Hospital, Angers · Updated on 2025-06-17

20

Participants Needed

5

Research Sites

108 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Angers

Lead Sponsor

C

Centre de Recheche du Centre Hospitalier Université Laval

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial investigates the feasibility of integrating immersive virtual reality (VR) technology into a functional restoration program (FRP) for patients with chronic low back pain (CLBP). The study aims to assess the acceptability, usability, and impact of a VR headset on both healthcare providers and patients participating in a group-based rehabilitation program. Chronic low back pain is a leading cause of functional disability worldwide and significantly impacts quality of life. Current rehabilitation strategies, including FRP, focus on improving physical functioning through multidisciplinary approaches. However, the role of emerging technologies, particularly VR, in enhancing these rehabilitation programs remains underexplored. VR has already shown promise in reducing chronic pain and improving motor abilities, but its application in a group rehabilitation context for CLBP is novel. The study will recruit healthcare providers and patients from several centers that are part of the Lombaction network. Participants will use a VR headset designed specifically to improve motor skills and reduce pain. The primary objective is to evaluate the acceptability of the VR device by healthcare providers and patients, as well as the usability and adherence to the VR program. Secondary objectives include assessing the impact of VR on kinesiophobia, pain, functional abilities, and motor imagery capabilities. This pilot study will provide valuable insights into the feasibility of incorporating VR into group-based rehabilitation programs, offering a foundation for larger comparative trials aimed at evaluating the long-term effectiveness of VR in improving rehabilitation outcomes for chronic low back pain.

CONDITIONS

Official Title

VRFR- Immersive Virtual Reality Use in a Spine Functional Restoration Program - A Feasibility Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers involved in functional restoration programs at participating centers who will use the VR tool.
  • Caregivers who consent to participate.
  • Patients aged 18 to 65 years.
  • Patients diagnosed with chronic low back pain lasting more than three months with secondary causes excluded.
  • Patients eligible for a functional restoration program at a participating center.
  • Patients affiliated with or beneficiaries of a social security scheme.
  • Patients who provide informed consent to participate.
Not Eligible

You will not qualify if you...

  • Conditions incompatible with the functional restoration program.
  • Surgery or trauma within the last month.
  • Contraindications to VR use such as unstable epilepsy, facial trauma in the last three months, hearing or vision impairments, or prior VR-induced pain, dizziness, or nausea.
  • Visual impairments preventing VR device use.
  • Pregnancy or breastfeeding.
  • Poor comprehension of the French language.
  • Incarceration by judicial or administrative decision.
  • Undergoing compulsory psychiatric treatment.
  • Subject to legal protection measures.
  • Unable to provide informed consent.

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Les capucins

Angers, France, 49103

Actively Recruiting

2

CH Cholet

Cholet, France, 49325

Actively Recruiting

3

CH Laval

Laval, France, 53015

Actively Recruiting

4

CHU Rennes

Rennes, France, 35033

Actively Recruiting

5

Centre Hospitalier Bretagne Atlantique - Site de vannes

Vannes, France, 56017

Actively Recruiting

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Research Team

R

Romain CHAMPAGNE, MD

CONTACT

A

Anthéa LOIEZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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