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临床试验/NCT07527845
NCT07527845已完成不适用

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

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Simulator Sickness Questionnaire (SSQ)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Healthy Volunteers (Pilot Phase)

Description: A group of healthy volunteers (n=7) over 18 years old with no chronic pathologies or musculoskeletal conditions Role: This group was used for the initial testing and iterative development of the AnReal system to evaluate user experience and baseline cybersickness. Feedback from this group led to technical modifications of the software before testing it with the clinical population

干预措施: Augmented Reality (AR) Rehabilitation System (Device)

Patients with Chronic Low Back Pain (Feasibility Phase)

Description: A group of patients (n=10) over 18 years old diagnosed with non-specific chronic low back pain for more than three months, presenting with kinesiophobia and limited range of motion (less than 40 degrees of spinal forward bending).

Role: This is the primary clinical cohort used to evaluate the feasibility, safety, and potential impact of the AR-based intervention on pain-related fear and physical movement

干预措施: Augmented Reality (AR) Rehabilitation System (Device)

结局指标

主要结局

Simulator Sickness Questionnaire (SSQ)

时间窗: 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.

次要结局

  • Peak Angle of Spinal Forward Bending(During the intervention session (recorded across 10 to 12 repetitions))
  • Qualitative Feedback on System Experience and Safety(Immediately following the intervention session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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