An interventional study of Virtual Reality-Supported Rehabilitation and Usual Care in Chronic Pain and Kinesiophobia (Fear of Movement), sponsored by Laval University. Recruiting at 2 sites in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
Chronic pain is common among adults aged 65 and older and can reduce mobility, independence, mood, and quality of life. Many older adults also develop a fear of movement because they worry that physical activity will increase their pain or cause injury. This fear can lead to reduced activity, physical deconditioning, and further loss of independence. This study aims to evaluate the feasibility, acceptability, and potential impact of Moving Without Fear or Pain, a program using immersive virtual reality rehabilitation to gradually reintroduce movement in a safe and engaging way.
The virtual reality intervention includes up to eight individualized sessions over approximately one month. Sessions last 5 to 30 minutes and are supervised by a trained clinician. Participants wear a virtual reality headset and are immersed in calming or engaging environments, such as nature settings. Depending on their comfort and abilities, sessions may begin with passive guided motor imagery and progress to active movement within interactive virtual environments. Some applications allow participants to control movement in the virtual world through gentle physical activity, such as stepping or upper-body movement. The intervention is personalized to each participant's physical capacity, preferences, and rehabilitation goals. The aim is to reduce fear of movement, increase confidence, and promote safe re-engagement in physical activity. In this pilot randomized controlled trial, 24 older adults with chronic pain will be randomly assigned to one of two groups: 1) Experimental Group: Participants will receive care, and up to eight immersive virtual reality rehabilitation sessions. 2) Control Group: Participants will receive usual care, without virtual reality sessions. The findings will inform a larger future study.
Chronic pain in older adults is a complex and multidimensional condition that affects physical function, emotional well-being, social participation, and overall quality of life. In this population, persistent pain is frequently accompanied by fear of movement and maladaptive beliefs about pain, which can lead to activity avoidance and progressive functional decline. Many older adults reduce their physical activity not only because of pain itself, but because of the anticipation that movement will worsen symptoms or cause injury. Over time, this avoidance can contribute to muscular deconditioning, reduced balance, increased frailty, and greater dependence in daily activities.
This study is grounded in the biopsychosocial model of chronic pain, which integrates biological, psychological, and social contributors to the pain experience. The intervention is designed to engage these interacting domains simultaneously. On a biological level, gradual activation of the motor system and re-engagement in movement may help counteract deconditioning. On a psychological level, reducing fear-based avoidance may improve confidence and perceived control. On a social and emotional level, increasing engagement and exposure to meaningful environments may support mood and motivation.
Immersive virtual reality offers a novel therapeutic platform capable of supporting graded exposure to movement in a controlled and engaging manner. Immersive virtual environments create a strong sense of presence, meaning that users feel situated within the simulated environment rather than observing it from a distance. This immersive quality may increase attentional absorption, reduce pain salience, and enhance emotional engagement. Virtual environments can also provide positive and calming experiences, including exposure to natural landscapes, which have been associated with improved mood and reduced stress. In addition, interactive virtual systems can translate gentle physical movements into forward progression within the environment, allowing participants to experience movement success in a supportive context.
The intervention evaluated in this study integrates immersive virtual reality rehabilitation session. The virtual component is personalized and adapted to the participant's functional capacity, preferences, and rehabilitation goals. The progression within the immersive experience is gradual. Participants may begin with exposure to immersive environments that require no active physical movement, allowing them to become comfortable with the technology and to engage in guided motor imagery. As confidence increases, the intervention may incorporate gentle physical movements that influence navigation within the virtual space. This graded approach is designed to reduce fear while reinforcing positive movement experiences. The immersive environments are selected to promote safety, engagement, and enjoyment, with careful monitoring for tolerability.
The primary purpose of this pilot study is not to establish definitive clinical efficacy, but rather to evaluate feasibility, acceptability, and implementation practicality in older adults with chronic pain. The study seeks to determine whether the combined approach can be delivered safely within clinical and residential care settings, whether participants are willing to engage with immersive technology, and whether clinicians can integrate the intervention into routine workflows. The study also aims to estimate variability in key clinical measures in order to inform sample size calculations for a future larger trial.
Several conceptual mechanisms may contribute to potential benefit. Engagement in immersive environments may reduce attentional focus on pain, temporarily lowering perceived intensity. Guided motor imagery and graded movement may activate motor-related neural networks without triggering excessive threat responses. Repeated positive movement experiences may weaken fear-based associations. Improvements in confidence and perceived control may facilitate behavioral activation and adherence to rehabilitation. Exposure to calming natural environments may influence mood and stress regulation. These interacting processes reflect the integrated biopsychosocial rationale of the intervention.
The pilot design allows systematic documentation of recruitment flow, adherence patterns, participant retention, tolerability of immersive exposure, and practical barriers to implementation. The study also examines whether older adults with varying levels of physical function and technological familiarity can engage with immersive systems when provided appropriate supervision and support. Safety considerations are central, including monitoring for cybersickness symptoms such as dizziness, nausea, or disorientation. The intervention is delivered under trained supervision, and participants may discontinue at any time without impact on usual care.
By focusing on feasibility and implementation in real-world contexts rather than tightly controlled laboratory conditions, the study aims to generate information that is directly relevant to clinical translation. The results will inform refinement of procedures, optimization of session pacing, identification of appropriate safety parameters, and clarification of training needs for clinicians. Ultimately, this pilot phase is intended to support the development of a larger, adequately powered randomized controlled trial designed to evaluate the clinical effectiveness of immersive virtual reality-supported rehabilitation for chronic pain in older adults.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive usual care and up to eight individualized immersive virtual reality rehabilitation sessions delivered over approximately one month. Virtual reality sessions are supervised by trained clinicians and may include guided motor imagery, immersive nature environments, and graded interactive movement adapted to participant capacity and goals.
Device: Virtual Reality-Supported Rehabilitation · Other: Usual Care
Participants receive usual care.
Other: Usual Care
Immersive virtual reality rehabilitation sessions delivered under clinician supervision, using guided motor imagery, immersive natural environments, and graded interactive movement adapted to participant capacity and goals. Following completion of the educational session, participants engage in immersive virtual reality rehabilitation delivered under clinician supervision. The virtual reality component uses a head-mounted display to immerse par
Also known as: VR-Based Rehabilitation
Participants continue to receive their usual care throughout the study period.
Change in Kinesiophobia as Measured by the Tampa Scale of Kinesiophobia (TSK-11)
Kinesiophobia will be assessed using the 11-item Tampa Scale of Kinesiophobia (TSK-11). Scores range from 11 to 44, with higher scores indicating greater fear of movement. The primary analysis will evaluate change in TSK-11 score from baseline to post-intervention.
Time frame: Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)
Feasibility of the Multimodal Intervention
Feasibility will be evaluated using recruitment rate (proportion of eligible individuals who consent), adherence (proportion of intervention sessions completed), retention/attrition rate (proportion of participants completing the study), and documentation of adverse events and protocol deviations.
Time frame: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
Acceptability of the Multimodal Intervention
Acceptability will be assessed using structured participant and clinician questionnaires administered before and after the intervention, including Likert-scale ratings of satisfaction, perceived usefulness, usability of virtual reality, and perceived barriers to participation.
Time frame: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
Change in Fear-Avoidance Beliefs as Measured by the Fear Avoidance Component Scale (FACS)
Fear-avoidance beliefs will be assessed using the Fear Avoidance Component Scale (FACS), a self-reported questionnaire designed to comprehensively measure fear-avoidance components in individuals with painful medical conditions. The FACS includes 20 items, each rated on a Likert scale from 0 = completely disagree to 5 = completely agree. The total score is calculated by summing all item scores and ranges from 0 to 100. Higher scores indicate worse outcomes, namely greater fear-avoidance beliefs and behaviors related to pain and movement. Scores can be categorized into five severity levels: Subclinical = 0 to 20, Mild = 21 to 40, Moderate = 41 to 60, Severe = 61 to 80, and Extreme = 81 to 100.
Time frame: Baseline to post-intervention (approximately 4 weeks)
Change in Emotional State as Measured by the Profile of Mood States (POMS)
Emotional state will be assessed using the Profile of Mood States (POMS), a self-reported questionnaire that evaluates mood across six domains: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, vigor-activity, and confusion-bewilderment. The POMS includes 65 items, each rated on a 5-point scale from 0 = not at all to 4 = extremely. The Total Mood Disturbance score is calculated by summing the negative mood subscales - tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, and confusion-bewilderment - and subtracting the vigor-activity score. The possible Total Mood Disturbance score ranges from -32 to 200. Higher Total Mood Disturbance scores indicate worse outcomes, reflecting greater overall emotional distress. For individual subscales, higher scores indicate worse outcomes for the negative mood domains and better outcomes for the vigor-activity domain. Subscale score ranges are as follows: tension-anxiety, 0 to 36; depression-dejection, 0
Time frame: Baseline to post-intervention (approximately 4 weeks)
Change in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (PCS)
Pain-related catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS). Total scores range from 0 to 52, with higher scores indicating greater levels of rumination, magnification, and helplessness related to pain. The outcome measure will evaluate change in PCS score from baseline to post-intervention.
Time frame: Baseline to post-intervention (approximately 4 weeks)
Self-Reported Percentage of Pain Relief
Participants will report the percentage of overall pain relief experienced following the intervention. Responses will range from 0% (no relief) to 100% (complete relief). This measure captures perceived global improvement in pain.
Time frame: Post-intervention (approximately 4 weeks)
Cybersickness as Measured by the Simulator Sickness Questionnaire (SSQ)
Tolerance to immersive virtual reality will be assessed using the Simulator Sickness Questionnaire (SSQ), a widely used tool for measuring cybersickness symptoms in virtual environments. The SSQ assesses three main dimensions: nausea, oculomotor symptoms, such as visual fatigue, and disorientation. The SSQ includes 16 symptoms, each rated from 0 = none to 3 = severe. The weighted total score ranges from 0 to 179.52, with higher scores indicating worse outcomes, meaning greater severity of cybersickness symptoms.
Time frame: Assessed during and after virtual reality sessions (up to approximately 4 weeks)
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in publications will be made available upon reasonable request after publication of the primary study results. Data will include de-identified demographic variables and outcome measures.
Supporting information: Study protocol
Time frame: De-identified individual participant data and the study protocol will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years following publication.
Access criteria: De-identified individual participant data and supporting documentation (study protocol) will be made available to qualified researchers upon reasonable request. Access will be granted to researchers who provide a methodologically sound research proposal and who agree to a data use agreement in accordance with institutional, ethical, and legal requirements. Requests will be reviewed by the principal investigator and research team. Data will be shared in de-identified form to protect participant confidentiality.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 6 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
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