NCT07293312

Optimizing the Use of Virtual Reality in Rehabilitation for Individuals With Persistent Shoulder Pain

Optimizing the Use of Virtual Reality in Rehabilitation for Individuals With Persistent Rotator Cuff-related Shoulder Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is to investigate the effect of a block of four specific virtual reality (VR) exercises on upper limb function, pain, kinesiophobia, and pain catastrophizing in individuals with rotator cuff-related shoulder pain (RCRSP). The secondary objective is to examine participants' tolerability of different VR interventions. Study Procedures: Participants will: * Attend a face-to-face assessment to confirm eligibility and receive a standardized pain neurophysiology education session (week 0). * Visit the clinic once weekly for four weeks to undergo the VR interventions and review pain education concepts (Weeks 5 to 8). * Complete online questionnaires evaluating upper limb function, kinesiophobia, pain, sense of presence, and cybersickness. Interventions Four VR interventions will be tested: * Unimanual distraction task with normal visual feedback * Bimanual distraction task with normal visual feedback * Unimanual reaching task with augmented visual feedback * Unimanual reaching task with diminished visual feedback Findings will guide clinicians in selecting the most effective VR interventions for shoulder impairment and assess the feasibility of implementing VR in a private physiotherapy clinic for individuals with RCRSP.

Detailed description

The use of virtual reality (VR) in rehabilitation has been shown to have positive effects on function and could enhance current rehabilitation interventions. However, the type of exercise to be performed, the specific added value of VR and the tolerance of the interventions performed remain poorly documented, which limits its clinical use. The primary objective of this project is to study the impact on function, pain, kinesiophobia and pain catastrophizing of a block of four specific VR exercises in individuals with chronic rotator cuff-related pain (RCRSP). The secondary objective is to examine participants' tolerance for different VR interventions. Thirty adults with RCRSP will be recruited to participate in the study. Each participant will complete three assessment sessions: initial, pre-intervention, and post-intervention. The initial assessment will be conducted in person four weeks prior to the intervention to verify eligibility and provide standardized education on the neurophysiology of pain. This educational session aims to ensure a common level of understanding, improve adherence to the VR sessions, and facilitate the transfer of VR movements to daily activities. The effect of the education will be assessed during the pre-intervention evaluation (week 4), conducted within seven days before the first VR session. The post-intervention evaluation (week 8), conducted within seven days following the 4-week intervention, will be used to address the study's primary objective. All questionnaires administered during the assessments and interventions will be completed online via REDCap. The intervention will consist of four VR rehabilitation sessions, each involving a distinct type of task: 1)Unimanual distraction task with normal visual feedback; 2) Bimanual distraction task with normal visual feedback; 3) Unimanual reaching task with augmented visual feedback; and, 4) Unimanual reaching task with diminished visual feedback. Outcome measures will include upper limb function, kinesiophobia, pain, participant satisfaction, sense of presence, and cybersickness. To address the primary objective, repeated-measures ANOVAs will be conducted to compare outcomes across the three assessment time points (initial, pre-intervention \[week 4\], and post-intervention \[week 8\]). To address the secondary objective, repeated-measures ANOVAs will also be used to compare the effects of the different intervention types (unimanual vs. bimanual; augmented vs. diminished visual feedback). This project will have an impact on both upper limb rehabilitation and the use of emerging VR technology in clinical settings. The project will provide a better understanding of the impact of VR intervention on symptoms, which is an important prerequisite for using VR in this population. It will also explore the type of intervention to be recommended in VR in complement to pain education.

Conditions

• Rotator Cuff Related Shoulder Pain

Interventions

Type	Name	Description
OTHER	Virtual reality unimanual distraction task	Unimanual tasks (performed with the affected limb) with unaltered visual feedback will involve distraction exercises in which participants move a tray toward targets while keeping a ball balanced on the tray. Three trials with varying levels of friction between the ball and tray will be presented to manipulate the task's difficulty.
OTHER	Virtual reality bimanual distraction task	Bimanual tasks with unaltered visual feedback (targets positioned based on the affected limb) will involve distraction exercises in which participants move a tray toward targets while keeping a ball balanced on the tray. Three trials with varying levels of friction between the ball and tray will be presented to adjust task difficulty.
OTHER	Virtual reality unimanual reaching tasks with augmented visual feedback	Three trials with varying levels of visual feedback alteration will be performed, corresponding to a 0%, 25%, or 50% amplification of movement in the virtual environment compared to the real world. While virtual targets will appear farther apart, the actual movement required to reach them will remain the same across all trials.
OTHER	Virtual reality unimanual reaching tasks with decreased visual feedback	Three trials with varying levels of visual feedback alteration will be performed, corresponding to a 0%, 17%, or 33% reduction in movement in the virtual environment compared to the real world. Although the virtual targets will appear closer together, the actual movement required to reach them will remain the same across all trials.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: Canada