The Effects of Immersive Virtual Reality-Based Exercise Therapy on Pain, Functionality, Sleep, and Cognitive Functions in Patients With Grade 1-2 Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain intensity measured by the Visual Analog Scale (VAS)
研究概览
简要总结
Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. It is most commonly observed in individuals aged between 40 and 60 years, and its treatment frequently involves approaches such as manual therapy, exercise, corticosteroid injections, and electrotherapy. However, these conventional methods may be limited by factors such as lack of motivation, pain-related avoidance behavior, and poor treatment adherence.
Today, immersive virtual reality technologies introduce a new dimension to rehabilitation by gamifying exercise, providing sensory feedback, and enabling graded exposure through mechanisms such as distraction and engagement. They also enhance motivation and compliance with exercise programs. Studies in the literature have reported that virtual reality-based exercise is an effective method for reducing pain levels in patients diagnosed with frozen shoulder.
However, only a limited number of studies have specifically examined the effects of immersive virtual reality in patients with adhesive capsulitis. To date, no study has investigated the impact of immersive virtual reality interventions on sleep and cognitive functions in these patients. Furthermore, the combined effect of patient education, home exercise programs, and immersive virtual reality therapy has not yet been explored. For these reasons, the present study aims to investigate the effects of immersive virtual reality-based exercise therapy on pain, functionality, sleep, and cognitive functions in patients with Grade 1-2 adhesive capsulitis.
详细描述
Our study was designed as a single-center, randomized, controlled, prospective trial aiming to compare the effectiveness of immersive virtual reality-based exercise therapy and conventional therapy in patients diagnosed with Grade 1-2 adhesive capsulitis.Patients who consent to participate will be randomly assigned to two groups:
Intervention Group (n = 15): Patient education + Home exercise program + Immersive virtual reality-based exercise therapy
Control Group (n = 15): Patient education + Home exercise program + Conventional exercise therapy
Intervention Process All participants will receive treatment twice a week for six weeks, with each session lasting 30 minutes. The initial assessment will be conducted before the first session, and the final assessment will take place at the end of the sixth week. Both the immersive virtual reality-based exercise group and the conventional exercise group will receive patient education. The educational content aims to describe the natural course of the disease, promote activity modification to encourage functional and pain-free range of motion, and adjust stretching intensity to suit the patient's current level.
Patient education will be delivered once, face-to-face, for 30 minutes before the interventions begin, and it will cover five main topics:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed with adhesive capsulitis by a doctor
- •Classified as Grade 1-2 adhesive capsulitis
- •Receiving physiotherapy for adhesive capsulitis for the first time
- •Aged between 18 and 64 years
- •Suitable for using a VR headset
排除标准
- •Previous history of physiotherapy
- •Presence of any mental disorder
- •Recent surgery or any shoulder condition (e.g., fractures around the shoulder region) that contraindicates shoulder mobilization
- •History of receiving injections
研究组 & 干预措施
Immersive Virtual Reality-Based Exercise Therapy
Participants in this group will receive immersive virtual reality-based exercise therapy using Oculus Quest 2 applications (Guided Tai Chi and Reach Shoulder Health) for 6 weeks, 2 sessions per week.
干预措施: Immersive Virtual Reality-Based Exercise Therapy (Other)
Conventional Physiotherapy Group
Participants in this group will receive standard physiotherapy exercises for adhesive capsulitis including ROM, stretching, and strengthening for 6 weeks, 2 sessions per week.
干预措施: Conventional Physiotherapy Group (Other)
结局指标
主要结局
Pain intensity measured by the Visual Analog Scale (VAS)
时间窗: Baseline and at the end of the 6-week intervention period
The VAS assesses perceived shoulder pain intensity on a 10-cm line from "no pain" to "worst pain imaginable.
次要结局
- Pain Catastrophizing (Pain Catastrophizing Scale - PCS)(Baseline and at the end of the 6-week intervention period)
- Benton Visual Retention Test(Baseline and at the end of the 6-week intervention period)
- Shoulder Function (Shoulder Pain and Disability Index - SPADI)(Baseline and at the end of the 6-week intervention period)
- Shoulder Range of Motion (ROM)(Baseline and at the end of the 6-week intervention period)
- Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)(Baseline and at the end of the 6-week intervention period)
- Virtual Reality Satisfaction Questionnaire(At the end of the first Virtual Reality session)
- Digit Span Test(Baseline and at the end of the 6-week intervention period)
- Wisconsin Card Sorting Test(Baseline and at the end of the 6-week intervention period)
- Virtual Reality Discomfort Questionnaire(At the end of the first Virtual Reality session)
研究者
Hande Besna Göçen
Lecturer, MSc Physiotherapist
Bahçeşehir University