Poliomyelitis, Severe Mobility Impairment, Spinal Cord Injuries (SCI)
Conditions
Keywords
Virtual reality, Chronic pain, Psychological distress, Quality of life
Brief summary
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.
Detailed description
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: Forty-eight participants experiencing chronic pain will be recruited from the Hong Kong Polytechnic University. At baseline, all recruited participants will be screened for neuropathic pain using the Douleur Neuropathique 4 Questions (DN4) questionnaire. Participants who score ≥4 will be classified into a neuropathic pain subgroup. To facilitate mechanism-based subgroup analysis in the EEG data processing, only participants in this specific subgroup will undergo an additional Quantitative Sensory Testing (QST, Medoc) at baseline. Besides, another healthy control group will be added to provide a normative reference for exploratory mechanistic analyses. Interventions: Participants will be randomly assigned to one of two arms: * Virtual walking group: Participants will engage in an arm-swing virtual walking intervention. This consists of a 13-minute session daily for 10 days. * Control group: Participants will receive a time-matched passive video observing control, watching walking videos for 13 minutes daily for 10 days. Instruments: Validated questionnaires, 64-channel EEG, and HRV monitoring. Qualitative Evaluation: Following the completion of the intervention, qualitative semi-structured interviews will be conducted with participants to explore their perceived effects, strengths, and limitations of the intervention.
Interventions
BEHAVIORALVirtaul walking
Participants in the intervention group will wear a head-mounted display and hold a controller to swing their arm and control the virtual avatar walking in the virtual natural scenarios. The intervention will include 10 scenarios of virtual walking intervention (1 scenario daily, each lasting for 13 minutes).
BEHAVIORALPassive observing video
Participants in the control group will watch 10 different walking videos in total, one for each day, each approximately 13 minutes.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline (T0), and up to 48 hours post-intervention (T1). | Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (0-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe). |
| Anxiety | Baseline (T0), and up to 48 hours post-intervention (T1). | Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of 7 items rated on a Likert scale from 0 to 3 (0 = not at all, 3 = nearly every day), with scores ranging from 0 to 21; higher scores indicate a higher level of anxiety severity. |
| Stress | Baseline (T0), and up to 48 hours post-intervention (T1). | Stress will be measured using the Chinese version of the Perceived Stress Scale (PSS-10). The PSS-10 consists of 10 items rated on a 5-point Likert scale (0 = never to 4 = very often), with total scores ranging from 0 to 40; higher scores indicate higher levels of perceived stress. |
| Quality of life (WHOQOL-100) | Baseline (T0), and up to 48 hours post-intervention (T1). | Quality of life will be measured using the Chinese version of the World Health Organization Quality of Life (WHOQOL-100). The WHOQOL consisted of 100 items from six domains: physical, psychological, level of independence, social relationships, environmental, and spiritual belief. The total score of each domain will be converted to 0 - 100, with higher scores indicating higher QOL. |
| Brain electrocortical activity | Baseline (T0), and up to 48 hours post-intervention (T1). | Brain electrophysiological activity will be assessed using a 64-channel electroencephalography (EEG) system (Neuroscan) at rest and during task-based states. At rest, EEG outcomes will include absolute and relative spectral power in the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-45 Hz) frequency bands. Alpha peak frequency will also be included. During the task-based assessment, event-related spectral perturbation (ERSP) will be calculated to assess event-related changes in spectral power within the pre-specified alpha (8-13 Hz) and beta (13-30 Hz) frequency bands. |
Countries
Hong Kong
Outcome results
None listed