Chronic PainVitaMoveNCT07607899
Virtual Reality for Pain and Well-Being in Older Adults
A study testing Virtual Reality-Supported Rehabilitation in people with Chronic Pain and Kinesiophobia (Fear of Movement), run by Laval University at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain, Kinesiophobia (Fear of Movement)
- What is being tested?
- Virtual Reality-Supported Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 14 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Able to understand and communicate in French
- Chronic pain lasting 6 months or longer
- Average pain intensity of 3 or greater on a 0-10 Numeric Rating Scale during the week prior to enrollment
- Score greater than 25 on the 11-item Tampa Scale of Kinesiophobia (TSK-11)
- No neurocognitive impairment (Mini-Mental State Examination [MMSE] ≥ 24), or mild neurocognitive impairment (MMSE 18-24) with preserved capacity to consent (University of California Brief Assessment of Capacity to Consent [UBACC] score ≥ 12)
- Normal or corrected-to-normal visual acuity
Who cannot join
- Severe motion sickness or intolerance that would prevent safe use of a virtual reality headset (experimental group only)
- Medical condition that would prevent safe participation in rehabilitation activities
- Presence of open wounds or infection at painful or contralateral sites
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CIUSSS de la Capitale-Nationale
Québec, Quebec
Line D'Amours (coordinatrice CEVQ), 418-906-7465, line.damours.ciussscn@ssss.gouv.qc.ca
- Recruiting
CISSS de Chaudière-Appalaches
Sainte-Marie, Quebec
Louis-Frédéric Lessard (conseiller en milieux de vie), 418-387-8181 ext. 48135, louis-frederic.lessard.cisssca@ssss.gouv.qc.ca
About this study
Official title: Moving Without Fear or Pain: Use of Immersive Virtual Reality to Reduce Pain and Improve Well-Being in Older Adults
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.
Read the detailed description
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.
- Conditions
- Chronic Pain, Kinesiophobia (Fear of Movement)
- Being tested
- Virtual Reality-Supported Rehabilitation, Usual Care
- Keywords
- Chronic Pain, Older Adults, Kinesiophobia, Fear of Movement, Empowered Relief, Biopsychosocial Model, Motor Imagery, Virtual Reality Rehabilitation, Non-Pharmacological Pain Management
- Medical subject headings
- Chronic Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Supported RehabilitationDevice
Also called VR-Based Rehabilitation
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
Usual CareOther
Participants continue to receive their usual care throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality and Usual Care | Experimental | 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. Receives: Device: Virtual Reality-Supported Rehabilitation; Other: Usual Care |
| Usual Care | Active comparator | Participants receive usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed during and after virtual reality sessions (up to approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start14 Sep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot randomized controlled trial using a parallel assignment design. Participants will be allocated to one of two groups: one group will receive immersive virtual reality rehabilitation sessions in addition to usual care, while the other group will receive usual care only. Both groups will be followed over the same study period. Randomization will be performed using a minimization procedure to balance key participant characteristics. The study is double-blind with respect to participants and the statistician analyzing the data
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, École de technologie supérieure, Université du Québec à Chicoutimi, Université de Sherbrooke
- Responsible party
- Principal investigator, Martine Bordeleau, Laval University
- Investigators
- Maude Laberge, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607899
- Sponsor's protocol ID
- MP-31-2026-6028
- Other IDs
- RQRV
- Acronym
- VitaMove
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving Without Fear or Pain: Use of Immersive Virtual Reality to Reduce Pain and Improve Well-Being in Older Adults
- ClinicalTrials.gov ID
- NCT07607899
- Acronym / sponsor ID
- VitaMove / MP-31-2026-6028
- Conditions
- Chronic Pain, Kinesiophobia (Fear of Movement)
- Keywords
- Chronic Pain, Older Adults, Kinesiophobia, Fear of Movement, Empowered Relief, Biopsychosocial Model, Motor Imagery, Virtual Reality Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- McGill University, École de technologie supérieure, Université du Québec à Chicoutimi, Université de Sherbrooke
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot randomized controlled trial using a parallel assignment design. Participants will be allocated to one of two groups: one group will receive immersive virtual reality rehabilitation sessions in addition to usual care, while the other group will receive usual care only. Both groups will be followed over the same study period. Randomization will be performed using a minimization procedure to balance key participant characteristics. The study is double-blind with respect to participants and the statistician analyzing the data
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality and Usual Care | Experimental | Device: Virtual Reality-Supported Rehabilitation, Other: Usual CareParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants receive usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 years or older
- Able to understand and communicate in French
- Chronic pain lasting 6 months or longer
- Average pain intensity of 3 or greater on a 0-10 Numeric Rating Scale during the week prior to enrollment
- Score greater than 25 on the 11-item Tampa Scale of Kinesiophobia (TSK-11)
Key exclusion criteria (3 listed)
- Severe motion sickness or intolerance that would prevent safe use of a virtual reality headset (experimental group only)
- Medical condition that would prevent safe participation in rehabilitation activities
- Presence of open wounds or infection at painful or contralateral sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Supported RehabilitationAlso: VR-Based RehabilitationImmersive 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 | Device | Virtual Reality and Usual Care |
| Usual CareParticipants continue to receive their usual care throughout the study period. | Other | Usual Care, Virtual Reality and Usual Care |
Primary outcome
Change in Kinesiophobia as Measured by the Tampa Scale of Kinesiophobia (TSK-11)
Time frame: Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)
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.
Feasibility of the Multimodal Intervention
Time frame: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
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.
Acceptability of the Multimodal Intervention
Time frame: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
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.
5 secondary outcomes
Change in Fear-Avoidance Beliefs as Measured by the Fear Avoidance Component Scale (FACS)
Time frame: Baseline to post-intervention (approximately 4 weeks)
Change in Emotional State as Measured by the Profile of Mood States (POMS)
Time frame: Baseline to post-intervention (approximately 4 weeks)
Change in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (PCS)
Time frame: Baseline to post-intervention (approximately 4 weeks)
Self-Reported Percentage of Pain Relief
Time frame: Post-intervention (approximately 4 weeks)
Cybersickness as Measured by the Simulator Sickness Questionnaire (SSQ)
Time frame: Assessed during and after virtual reality sessions (up to approximately 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maude Laberge, PhD principal investigator
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Supported Rehabilitation in people with Chronic Pain and Kinesiophobia (Fear of Movement), run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine Bordeleau, PhD (1-581-490-2626, martine.bordeleau@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kinesiophobia as Measured by the Tampa Scale of Kinesiophobia (TSK-11) (time frame: Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.