Recruiting

Moving Without Fear

Sponsor:

Laval University

Code:

NCT07607899

Conditions

Chronic Pain

Kinesiophobia (Fear of Movement)

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality-Supported Rehabilitation

Usual Care

Study Details

Brief 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. 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.

Conditions

Chronic Pain

Kinesiophobia (Fear of Movement)

Study ID

NCT07607899

Start date

Sep 14, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality and Usual Care

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.

active comparator: Usual Care

Participants receive usual care.

Interventions

Virtual Reality-Supported 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 Care

Participants continue to receive their usual care throughout the study period.

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) ]
  • Feasibility of the Multimodal Intervention [ Time Frame: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks) ]
  • Acceptability of the Multimodal Intervention [ Time Frame: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks) ]

Central Contacts and Locations

Central contacts

Martine Bordeleau, PhD

1-581-490-2626martine.bordeleau@outlook.com

Locations

CIUSSS de la Capitale-Nationale

Recruiting

Québec, Quebec, Canada

Contacts

Line D'Amours (coordinatrice CEVQ)

418-906-7465line.damours.ciussscn@ssss.gouv.qc.ca

CISSS de Chaudière-Appalaches

Recruiting

Sainte-Marie, Quebec, Canada

Contacts

Louis-Frédéric Lessard (conseiller en milieux de vie)

418-387-8181louis-frederic.lessard.cisssca@ssss.gouv.qc.ca

More Information

Sponsor

Laval University

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Chronic Pain
  • Older Adults
  • Kinesiophobia
  • Fear of Movement
  • Empowered Relief
  • Biopsychosocial Model
  • Motor Imagery
  • Virtual Reality Rehabilitation
  • Non-Pharmacological Pain Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Laval University on 2026-09-10.