跳至主要内容
临床试验/NCT07392762
NCT07392762尚未招募不适用

Virtual Reality-Supported Exercise for Chronic Musculoskeletal Shoulder Disorders: a Feasibility Study (The V-RECS Study)

Royal National Orthopaedic Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Consent rate

研究概览

简要总结

People with long-term (chronic) shoulder disorders caused by injuries, overuse or conditions (such as arthritis) often need physiotherapy. This usually includes exercise therapy to help reduce pain, rebuild strength and make every day activities easier. However, it can be hard to stick to an exercise programme. People may stop due to pain, fear of making the symptoms worse or simply loosing motivation.

Virtual Reality (VR) is a technology that may help people say engaged with their exercise programmes by making exercises more enjoyable and interactive. When using a headset (similar to goggles), people can see and interact with a 3D virtual world. Their movement, especially their hands and arms, are shown as an 'avatar' (a virtual character) in this virtual world. Exercise can feel more like playing a game or engaging with tasks/challenges, rather than performing repetitive movements. This shift might help reduce focus on pain and increase motivation. VR also provides real-time feedback, helping people track their progress and adjust their movements instantly. This might lead to more accurate and consistent exercise performance and better recovery outcomes.

Before we can test whether VR exercise programmes are effective for people with chronic shoulder disorders, we firstly need to understand whether it is practical and acceptable for patients to use. This 'feasibility' study will therefore involve 20 patients with chronic shoulder disorders referred for physiotherapy at the Royal National Orthopaedic Hospital (RNOH) in Stanmore, United Kingdom. Participants will take part in three VR exercise sessions at the RNOH over a three-week period. Levels of pain, quality of life and sleep quality etc. will be measured before and after three weeks. Interviews will also be held up to two weeks after the final session to explore people's experiences and thoughts towards the VR exercise programme. The results will help us decide if a larger study should go ahead.

详细描述

Chronic shoulder disorders are long-lasting problems that cause pain, stiffness, or weakness in the shoulder. 'Chronic' means the condition has lasted for more than three months. These issues can make everyday tasks like reaching, lifting, or getting dressed, painful and difficult. Chronic shoulder disorders are very common. They affect people of all ages, but are more likely to occur in adults over 40. It is estimated that shoulder pain is one of the most frequent reasons people see a doctor for muscle or joint issues and up to 1 in 4 people may experience shoulder pain at some point in their lives.

There are several reasons someone might develop a chronic shoulder disorder. These include: repeated use or overuse of the shoulder (common in certain jobs or sports), injuries, such as a fall or sudden strain, wear and tear with age, poor posture and conditions like arthritis, frozen shoulder, or tendon problems (e.g., rotator cuff injuries).

Physiotherapy involving exercise is a key component for treating many chronic shoulder disorders. National guidelines recommend it as a fist line option before trying injections or surgery. These exercise programmes usually involve stretching, strengthening, range of movement exercises. There is also evidence that regular guided shoulder exercises are just as effective as surgery for some people. Studies show that people with large rotator cuff tears for example improve in pain, movement and quality of life over two years with results similar to those seen after surgery. However, even though exercise therapy can help many people with chronic shoulder disorders, several factors impact their effect and how well they work. These include staying consistent, using proper technique and sticking to a routine. People often struggle to follow shoulder exercise programmes, especially on their own, because of pain, low motivation or lack of feedback. Finding ways to overcome these barriers is important.

Immersive Virtual Reality (VR) is a technology that lets people experience and interact with a 3D virtual world using a headset. This virtual world can be designed for different settings and tasks, using sights and sounds to make it feel real. When wearing the headset, users can interact with the virtual world, where their movements (especially their hands and arms) are displayed on a screen as a virtual character (avatar), which they can use to control and navigate the environment to interact with the tasks/games. These capabilities mean that VR may offer benefits for rehabilitation. It can help increase motivation, give instant feedback, distract from pain, improve joint movement, and slowly expose people to difficult situations. One major barrier to recovery amongst people with chronic shoulder disorders is kinesiophobia, or the fear of movement. People often avoid certain helpful movements because they anticipate pain or injury, which leads to more stiffness, weakness, and pain. VR might help overcome this by combining both mental and physical strategies. For example, it can safely expose people to movements and distract them from pain. Another benefit of VR is that it turns exercise into more of a game. This can make it more fun, less repetitive, and more motivating. VR also gives real-time feedback on how someone is doing, helping them set goals and track their progress.

In recent years, VR has become more established for treating people with pain or nerve problems, such as stroke, burns, phantom limb pain, or Complex Regional Pain Syndrome (CRPS). Research into treating chronic muscle and joint (MSK) conditions, like chronic shoulder disorders, has not progressed as much as research for nerve-related conditions. However, Virtual Reality (VR) is now approved in the United States (US) for treating lower back pain, and recent studies show it might help improve outcomes for a variety of MSK problems. For people with shoulder issues, VR could help improve treatment by changing how exercises are delivered.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients >18 years with diagnosed unilateral/ bilateral shoulder pain with/ without co-existing symptoms of instability and or stiffness (persisting > three months) generated from a Musculoskeletal origin
  • Patients who have been referred for conservative management
  • New or follow-up patients
  • Sufficient English to understand written materials/verbal instruction/or accompanied by family/friends able to translate
  • Patients who provide informed, written consent to enter the study

排除标准

  • Unable to provide informed consent
  • On a waiting list for surgery and/or injections
  • Referred for post-operative physiotherapy
  • Shoulder pain not originating from an MSK aetiology (such as hemiplegia or peripheral nerve injury)
  • Active history of seizures
  • Other relevant medical conditions deemed inappropriate for patients to participate e.g. visual impairment, unstable psychiatric illnesses.
  • Shoulder pain associated with bone metastasis
  • Currently taking part in any other upper limb research study
  • Patients who do not adequately understand verbal explanations or written information given in English (or are not accompanied by an interpreter/family member).

研究组 & 干预措施

Virtual Reality Exercise Programme

Experimental

Consenting participants will attend three VR exercise sessions delivered by an upper limb physiotherapist at the Royal National Orthopaedic Hospital (RNOH), using the SyncVR FIT platform.

The SyncVR FIT platform is designed to support unilateral or bilateral upper limb movement through a series of interactive games, tasks, and challenges delivered via a VR headset. Participants will use handheld controllers to engage with these activities, enabling the system to track upper limb motion. While wearing the headset, participants will see a virtual representation of their upper limbs-specifically their hands-within the VR environment. These virtual hands mirror the participants' real-time movements, enhancing the sense of immersion and embodiment. A tablet device will be used by the intervention provider to monitor the session.

干预措施: Virtual Reality (Device)

结局指标

主要结局

Consent rate

时间窗: During enrolment period

The consent rate will be used as a measure of recruitment and will be defined as the number of participants who provide informed consent divided by the total number of patients screened for eligibility, ie: number of people who consented/number of people approached) x 100.

Dropout rate

时间窗: From first treatment visit though completion of treatment (average of 3 weeks)

The dropout rate will be defined as the percentage of participants who started the study, but did not complete all three treatment visits.

次要结局

  • Pain Intensity - Numeric Pain Rating Scale (NPRS)(* Baseline (Pre-intervention), * Immediately before and after each treatment session (up to 3 visits), * One follow-up 1 visit (within 48 hours of the last treatment session, average of 3 weeks))
  • Shoulder Range of Movement(Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)
  • Disability - Shoulder Pain and Disability Index (SPADI)(Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)
  • Quality of Life - EuroQol- 5 Dimension (EQ-5D-3L)(Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)
  • Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)(Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)
  • Usability - System Usability Scale (SUS)(Follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)
  • Satisfaction - Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)(Follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)
  • Cybersickness in VR Questionnaire (CSQ-VR).(Immediately after treatment visit 1, 2, 3 and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).)

研究者

发起方
Royal National Orthopaedic Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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