Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment: A Pilot Randomized Controlled Trial and Electroencephalogram Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Chronic pain
研究概览
简要总结
This randomized controlled trial aims to: (1) examine the effects of virtual walking intervention on chronic pain (primary outcome), and on depression, stress, anxiety, and quality of life (secondary outcomes) compared with the passive observing video control group in individuals with SMI (primarily spinal cord injury and post-polio); (2) explore the neurological mechanism of virtual walking intervention using the resting-state and task-based electroencephalography (EEG); (3) understand their perceived effects, strengths, and limitations for the virtual walking intervention using semi-structured focus group interviews.
详细描述
Background: Severe mobility impairment (SMI) negatively impacts lifespan and quality of life, especially through chronic pain and emotional issues such as depressive symptoms. Researchers have developed treatments including pharmacological interventions, physical activities, complementary and alternative medicine, and psychological treatment to treat chronic pain and emotional issues. However, these approaches have limitations. Virtual walking interventions utilize arm-swing locomotion to create the illusion of walking, allowing individuals to experience walking in virtual natural scenes. These interventions have shown feasibility and preliminary effects on mood and pain reduction in people with spinal cord injury. However, prior work varies in locomotion design (e.g., passive observing, trigger-based, or arm-swing), dosage (session length and total dose), and a few studies incorporate objective biomarkers like EEG to test neurological mechanisms.
Thus, this study aims to examine the effects of virtual walking on chronic pain and psychological distress and to explore the neurological mechanisms of virtual walking using the resting-state and task-based EEG.
Design:
This study will be a single-blind, two-arm, parallel-group pilot randomized controlled trial (RCT).
Participants and Subgroup Stratification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People with SMI (the operational definition of SMI is inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record reported inability to walk across a small room, or dependence on a walking aid during walking for more than 6 months (Pahor et al., 2014));
- •At least 6 months post-injury and in stable status;
- •Persistent chronic pain (more than 3 months) with a reported Numerical Pain Rating Scale ≥ 4 (Villiger et al., 2017);
- •Had no changes in their pain medication regimen in the past month;
- •Able to communicate in Cantonese and to provide informed consent.
排除标准
- •Have severe cognitive impairment (a score < 6 on the Abbreviated Mental Test (Chu et al., 1995));
- •Had a history of moderate to severe brain injury;
- •Have neurological disorders which affect brain function (i.e., stroke, Alzheimer's, Parkinson's, epilepsy) that may confound EEG measures;
- •Have a severe psychiatric disorder (schizophrenia or major depression);
- •Have an upper limb condition influencing the use of VR (e.g., arthritis or upper limb amputation).
研究组 & 干预措施
Virtual walking group
Participants in the virtual walking group will experience virtual walking in 10 virtual natural scenarios by using arm swing locomotion.
干预措施: Virtaul walking (Behavioral)
Passive observing video group
Participants in the passive observing group will look at 10 matched walking videos.
干预措施: Passive observing video (Behavioral)
结局指标
主要结局
Chronic pain
时间窗: Baseline (T0), and up to 48 hours post-intervention (T1).
Chronic pain will be assessed using the Brief Pain Inventory (BPI). Mean scores of items 3 - 6 (pain severity) and 9A-9G (pain interference) are calculated. Each item is rated on a 0-10 scale. Higher scores indicate greater pain severity and interference with daily life.
次要结局
- Depression(Baseline (T0), and up to 48 hours post-intervention (T1).)
- Anxiety(Baseline (T0), and up to 48 hours post-intervention (T1).)
- Stress(Baseline (T0), and up to 48 hours post-intervention (T1).)
- Quality of life (WHOQOL-100)(Baseline (T0), and up to 48 hours post-intervention (T1).)
- Brain electrocortical activity(Baseline (T0), and up to 48 hours post-intervention (T1).)