Optimizing the Use of Virtual Reality in Rehabilitation for Individuals With Persistent Rotator Cuff-related Shoulder Pain
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Symptoms and functional limitations specific to the upper limbs
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be blinded to the specific VR interventions they will perform to prevent anticipation or adjustment of their movements based on the intervention. For instance, they will not know whether their movements will be amplified or diminished compared to real-life motion.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Symptoms and functional limitations specific to the upper limbs
时间窗: post-intervention (week 8)
The QuickDASH is an 11-item questionnaire, validated in individuals with rotator cuff-related shoulder pain, addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs. Higher scores indicate greater pain and functional limitations.
次要结局
- Symptoms and functional limitations specific to the upper limbs(pre-intervention (week 4))
- Functional limitations(post-intervention (week 8))
- Pain Severity(post-intervention (week 8))
- Pain-related fear(post-intervention (week 8))
- Pain catastrophizing(post-intervention (week 8))
- Participants' satisfaction with their condition(post-intervention (week 8))
- Pain severity related to the intervention(Immediately before, after and two days after each intervention (weeks 5 to 8))
- Cybersickness(Immediately after each intervention (weeks 5 to 8))
- Sense of presence(Immediately after each intervention (weeks 5 to 8))
- Satisfaction with interventions received(post-intervention (week 8))
研究者
Jean-Sébastien Roy
Full professor
Laval University