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

NCT ID: NCT07293312

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-12-31

Brief 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

Keywords

Musculoskeletal Disorders; Virtual reality; Education; Shoulder; chronic pain intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual reality interventions

All participants will complete a four-week intervention, performing one of the four types of virtual reality (VR) exercises per week, so that each participant experiences all four exercises:

1. Unimanual distraction task with normal visual feedback

2. Bimanual distraction task with normal visual feedback

3. Unimanual reaching task with augmented visual feedback

4. Unimanual reaching task with diminished visual feedback

During each session, participants will reach 18 targets positioned at heights of 60°, 90°, and 120° across three planes of motion (flexion, scaption, and abduction). Target positions will be adjusted to accommodate each participant's arm length and size. To ensure participant comfort, the session will end if repetitions are not completed within 2 minutes. The order of interventions will be randomized for each participant.

Group Type: EXPERIMENTAL

Virtual reality unimanual distraction task

Intervention Type: OTHER

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.

Virtual reality bimanual distraction task

Intervention Type: OTHER

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.

Virtual reality unimanual reaching tasks with augmented visual feedback

Intervention Type: OTHER

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.

Virtual reality unimanual reaching tasks with decreased visual feedback

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Rotator cuff-related shoulder pain (screen by phone and then confirmed by the physiotherapist at the initial evaluation: pain over the deltoid and/or upper arm region, pain associated with arm movement [painful arc of movement], and familiar pain reproduced with loading or resisted testing during external rotation of the arm) for at least 6 months
• Minimum score of 15/100 on the shortened version of the Disabilities of the Arm, Shoulder, and Hand (1.5 times the minimally clinically important difference)

Exclusion Criteria

• Unavailable for the 4 weeks intervention
• Cannot understand or read French
• Have a diagnosis of rheumatoid, inflammatory or neurodegenerative diseases
• Have received a corticosteroid injection or any other type of injection (e.g., platelet-rich plasma, prolotherapy, hyaluronic acid) in the past three months for their current condition
• Have bilateral shoulder pain
• Have pain in another upper limb joint
• Have signs of upper (e.g., bilateral paresthesia, hyperreflexia, or spasticity) or lower (e.g., decreased sensation or strength in dermatomes and myotomes, hypotonia, or hyporeflexia) motor neuron lesions
• History of shoulder surgery, dislocation, or fracture
• Presence of severe osteoarthritis, symptomatic acromioclavicular joint pathology, or adhesive capsulitis (defined as restriction of passive glenohumeral movement of at least 30% for two or more directions)
• Full thickness rotator cuff tear, identified by imaging or clinical tests (lag signs and gross weakness)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Jean-Sébastien Roy

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Mercier, OT,PhD

Role: STUDY_DIRECTOR

Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris)

Jean-Sébastien Roy, PT, PhD

Role: STUDY_DIRECTOR

Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris)

Locations

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, Canada

Countries

Canada

Central Contacts

Félix Fiset, PT, MSc

Role: CONTACT

Phone: 418-649-3735

Email: felix.fiset.1@ulaval.ca

Facility Contacts

Jean-Sébastien Roy, PT, PhD

Role: primary

Other Identifiers

2025-3292

Identifier Type: -

Identifier Source: org_study_id