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

Condition(s) studied

Investigational drug(s) / intervention(s)

Utilisability of an immersive VR device in a functional restoration program (FRP) for patients with chronic low back pain.: Patients participating will engage in three 20-minute VR sessions per week, in addition to the standard FRP program, for a duration of four to five weeks. The sessions will consist of a series of pre-programmed exercises designed to facilitate various trunk movements (flexion, extension, inclination, rotation) through exergames. Each exercise will last an average of 5 to 7 minutes. These exercises have been developed in collaboration between the company providing the VR device and the rehabilitation teams. Patients will be set up by a healthcare provider in a dedicated room for VR use. The provider will configure the device, assist the patient in donning it, and initiate the program, will remain present throughout the session to monitor for any adverse effect . While the specific exercises may vary, the total duration of the session will be 20 minutes, consisting of various exercises interspersed with breaks. The principal investigator will propose a standardized series of exercises,

Study summary

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.

Eligibility

Primary outcome measure(s)

• Acceptance of the VR system — 5 weeks (last day of Functional restoration program)
  a questionnaire based on the UTAUT 2 model

Trial sites (5)

More University Hospital, Angers trials in France

Other trials for the same condition