Feasibility, Acceptability, and Usability of a Tele-rehabilitation Combining Immersive Virtual Reality Exercises and Therapeutic Education for Chronic Non-specific Neck Pain: A Mixed-methods Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention (retention rate)
研究概览
简要总结
Background: Several randomized controlled trials have already investigated the efficacy of virtual reality treatment for chronic neck pain, however no study to date has investigated multimodal tele-rehabilitation, combining both specific neck exercises in immersive virtual reality and therapeutic education, in subjects with chronic non-specific neck pain.
Objectives: The primary objective of this mixed-methods pilot study is to determine the feasibility, acceptability, and usability of tele-rehabilitation combining immersive virtual reality exercises and therapeutic education in people with chronic non-specific neck pain. Secondary objectives are: 1) to investigate changes in clinical outcomes (range of motion, pain intensity, neck disability, illness perceptions, kinesiophobia, impression of change) ; 2) to explore the subjects' experience of tele-rehabilitation.
Methods: The duration of the intervention will be 6 weeks, including 5 virtual reality sessions (15-20 minutes per session, without supervision of the physiotherapist) and 1 teleconsultation session with a physiotherapist (30 minutes per session) per week. Participants will be assessed quantitatively before and after the intervention, and qualitatively after the intervention.
Discussion: Study findings will provide evidence concerning the feasibility, acceptability, and usability of multimodal tele-rehabilitation for chronic non-specific neck pain, using immersive virtual reality. This study may strengthen the scientific evidence for the use of immersive virtual reality at home in the treatment of chronic non-specific neck pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (over 18 years), men or women
- •Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain), with or without referred pain in the upper limbs or the head
- •Neck Disability Index score greater than or equal to 5/50
- •Numerical Pain Rating Scale score greater than or equal to 3/10 (average pain over the past week)
- •To speak fluent French and to be able to provide informed consent
排除标准
- •Age under 18 years
- •Specific cause responsible for the neck pain (tumor/cancer, fracture, trauma, inflammatory disease, infection, compression or lesion of the spinal cord, surgery of the cervical spine, vascular pathology, neurological pathology, ligamentous lesion of the upper cervical spine, congenital disease of the cervical spine, chronic diffuse pain)
- •Neck Disability Index score less than 5/50
- •Numerical Pain Rating Scale score less than 3/10 (average pain over the past week)
- •Signs of untreated sensorimotor dysfunction (vertigo, vestibular disorders/pathologies, etc.) that interfere with the use of virtual reality
- •Visual problems (uncorrected myopia, limited vision after correction, eye surgery) that interfere with the use of virtual reality
- •Altered comprehension, significant cognitive impairment, inability to speak French, deafness, pregnancy, inability to provide written informed consent
结局指标
主要结局
Feasibility of the intervention (retention rate)
时间窗: At the end of the intervention (at 6 weeks)
Retention rate (i.e., percentage of participants who completed the study).
Usability of the virtual reality system and the online consultations
时间窗: At the end of the intervention (at 6 weeks)
Usability of the virtual reality system and the online consultations (assessed via the System Usability Scale (SUS) questionnaire and during the semi-structured interview). The SUS is a 10-item self-reported questionnaire assessing the usability of the interactive systems. Each item is scored from 1 ("do not agree at all") to 5 ("completely agree"). The total score ranges from 0 to 100, and higher scores reflect higher usability.
Feasibility of the intervention (online consultations)
时间窗: At the end of the intervention (at 6 weeks)
Number and duration of the online consultations.
Feasibility of the intervention (adhesion)
时间窗: During the intervention (6 weeks)
Adhesion to treatment (i.e., percentage of exercise sessions completed in relation to the total number of sessions prescribed, as well as the duration and frequency of the sessions).
Feasibility of the intervention (safety)
时间窗: During the intervention (6 weeks)
Safety (i.e., adverse events (type, frequency, severity) occurring during the intervention, assessed using a list of symptoms based on the Simulator Sickness Questionnaire and during the semi-structured interview).
Feasibility of the intervention (implementation at home)
时间窗: At the end of the intervention (at 6 weeks)
Implementation of the intervention at home (assessed during the semi-structured interview).
Acceptability (satisfaction) of the tele-rehabilitation
时间窗: At the end of the intervention (at 6 weeks)
Satisfaction with the tele-rehabilitation (online consultations, weekly follow-up, virtual reality exercises,...) using 5-point Likert-scale questions (from "not at all satisfied" to "very satisfied") and during the semi-structured interview.
次要结局
- Change in range of motion(Pre-intervention and at the end of the intervention (at 6 weeks))
- Experiences of the intervention(At the end of the intervention (at 6 weeks))
- Change in neck disability(Pre-intervention and at the end of the intervention (at 6 weeks))
- Change in illness perception(Pre-intervention and at the end of the intervention (at 6 weeks))
- Change in pain intensity(Pre-intervention and at the end of the intervention (at 6 weeks))
- Global perceived effect(At the end of the intervention (at 6 weeks))
- Change in kinesiophobia(Pre-intervention and at the end of the intervention (at 6 weeks))