JMIR Publications

ABSTRACT

Background:

Studies suggest that 40%-65% of stroke survivors develop chronic post-stroke pain (CPSP), which severely affects their quality of life and mental health. Empirical evidence suggests that existing treatments often fall short, underscoring the need for innovative, integrative interventions. Virtual Reality (VR) seems to provide valuable tools in stroke rehabilitation. Also, contextual-behavioural psychological approaches, such as Acceptance and Commitment Therapy (ACT), offer promising pain management and mental health resources, which seem to be feasible in VR formats. However, their combined application in CPSP remains unexplored. Trial Registration: NCT06990646 registered on clinicaltrials.gov. Trial status: not yet recruiting. Registered 21st May 2025. https://register.clinicaltrials.gov/prs/beta/studies/S000FU3N00000043/recordSummary

Objective:

This study protocol describes the VR-ACT study, which will test the feasibility and preliminary efficacy of an 8-week VR-ACT program for CPSP.

Methods:

A pilot randomized controlled trial (N = 30) will compare a VR-based ACT intervention with a sham-VR control. The study will follow a mixed-methods approach. Quantitative outcomes include pain intensity, psychological symptoms, and quality of life (via self-report measures), and brain network connectivity of the Triple Network (via fMRI). Feasibility will be evaluated through adherence, engagement, and acceptability. Qualitative feedback will be collected post-intervention.

Results:

The study expects that the VR-ACT program will be feasible, based on adherence, engagement, and acceptability. VR-ACT is expected to be significantly more effective than Sham VR in reducing pain, disability, and psychological symptoms, improving quality of life, and decreasing triple network brain connectivity (as measured by fMRI).

Conclusions:

This trial is expected to corroborate the hypothesis that a VR-delivered ACT program is a feasible, acceptable, and potentially effective tool to support pain self-management and mental health in CPSP patients, laying the groundwork for larger, multicenter trials. Clinical Trial: NCT06990646 registered on clinicaltrials.gov. Trial status: not yet recruiting. Registered 21st May 2025. https://register.clinicaltrials.gov/prs/beta/studies/S000FU3N00000043/recordSummary