Skip to main content
OpenTrials
Completed

NCT Number: NCT07527845

Feasibility of an Augmented Reality Novel Approach for the Rehabilitation of Chronic Low Back Pain Patients With Kinesiophobia

The goal of this clinical trial is to evaluate the feasibility, safety, and initial effectiveness of a new augmented reality (AR) system in adults over 18 years old suffering from chronic low back pain and kinesiophobia (fear of movement).

The main questions it aims to answer are:

Is the AR system safe to use and well-tolerated by participants without causing significant motion sickness or discomfort?

Can the visual "illusion" provided by the AR technology help patients increase their range of motion and reduce their fear of bending forward?

Participants will:

* Perform 10 to 12 repetitions of spinal bending exercises while wearing an AR headset that shows a video of them moving further than they actually are. * Complete questionnaires regarding their pain levels, physical disability, and fear of movement. * Report any symptoms of "cybersickness" (like dizziness or nausea) experienced during the use of the technology. * Participate in a brief interview to discuss their experience, how they felt using the device, and provide suggestions for improvement.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pontificia Universidad Católica de Chile

Santiago, Chile

About this study

Background and Scientific Rationale Chronic low back pain (CLBP) is frequently associated with kinesiophobia, an irrational and debilitating fear of physical movement rooted in the anticipation of pain. This fear often leads to avoidance behaviors, which further limit functional recovery and perpetuate disability. While traditional physical therapy is the standard of care, it often struggles to bypass these psychological barriers. This study explores the use of "AnReal," a novel rehabilitation system that integrates augmented reality (AR) and computer vision to facilitate movement through sensory recalibration.

The AnReal Technology The intervention utilizes an Android-based mobile application paired with a low-cost virtual reality headset. The system employs computer vision algorithms to track the patient's spinal flexion in real-time. The core technical innovation is a visual feedback loop: as the patient performs a forward bending motion, the AR interface generates a visual illusion-via a synchronized video-showing the patient's body continuing the movement beyond their actual physical limit.

Study Procedures

Healthy participants and low back pain patients undergo a session consisting of 10 to 12 repetitions of spinal forward bending guided by the AnReal system. During each repetition, the technology tracks the peak angle of flexion and provides real-time visual cues to encourage progress. Following the physical task, a mixed-methods approach is used to evaluate the experience:

  • Quantitative Assessment: Evaluation of cybersickness symptoms and user experience scores.
  • Qualitative Assessment: Semi-structured interviews to capture perceptions of safety, movement harmony, and the convincing nature of the visual illusion.

This pilot trial focuses on establishing the feasibility and safety of this task-specific AR tool as a potential complement to traditional physical therapy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be over 18 years old.
  • For the pilot phase: Healthy volunteers with no chronic pathologies or musculoskeletal conditions
  • For the clinical phase: Diagnosis of non-specific chronic low back pain (CLBP) lasting longer than three months.
  • For the clinical phase: Presence of less than 40 degrees of spinal forward bending movement.

Exclusion criteria

  • History of spine surgery.
  • Diagnosis of vestibular disorders.
  • Diagnosis of Meniere's syndrome

Treatment and study plan

Augmented Reality (AR) Rehabilitation System

Device

System Components: An Android-based mobile application used in conjunction with a low-cost virtual reality (VR) headset.

Technical Core: The system integrates computer vision algorithms and artificial intelligence to track and analyze spinal forward bending in real-time.

Visual Feedback Loop: It creates a visual illusion of continued movement, showing the patient's body performing a greater range of motion than they are actually executing.

Mechanism: This task-specific intervention uses visual cues and graded exposure to reduce fear of movement (kinesiophobia) and encourage a greater range of motion in patients with chronic low back pain

Other names: AnReal

Primary outcomes

  1. Simulator Sickness Questionnaire (SSQ)

    Time frame: Immediately after the technology testing session (single assessment)

    A standardized questionnaire used to evaluate symptoms of cybersickness (dizziness, nausea, etc.) associated with the use of the AR headset. It measures 16 symptoms across three subscores: Nausea, Oculomotor, and Disorientation. The total score represents the overall severity of the symptoms.

Secondary outcomes

  1. Peak Angle of Spinal Forward Bending

    Time frame: During the intervention session (recorded across 10 to 12 repetitions)

    The maximum angle of spinal flexion (in degrees) achieved by the participant while using the AR device. This measures the physical response to the visual feedback provided by the system.

  2. Qualitative Feedback on System Experience and Safety

    Time frame: Immediately following the intervention session

    Data collected through semi-structured interviews regarding the participants' perception of safety, the harmony of the movement, and their motivation to move further.

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.