A New Perspective on Mirror Therapy: The Effect of Leap Motion-Based Multi-Axis Immersive Virtual Reality Mirror Therapy (LISA) on Upper Extremity Functions in Individuals With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
The aim of this study is to examine the effectiveness of 3D virtual reality assisted mirror therapy based rehabilitation applications compared to classical methods used in stroke rehabilitation.
详细描述
Stroke is a common neurological condition and one of the significant causes of disability and death. For this reason, stroke is one of the leading causes of disability in adulthood and increases health expenditures in this area. Post-stroke rehabilitation is effective in accelerating recovery and reducing the impact of long-term disabilities, but more studies are needed to understand its specific implications.
Virtual reality applications are a method that has been developing rapidly with the development of technology since the 1980s and is used more widely in simulations and games today. Virtual reality and interactive video games have started to be used as a new treatment method in stroke rehabilitation. The advantage of this method is that it allows the patient to use activity methods that cannot be reached or used in the clinical setting, with plenty of repetitive and visual feedback. Moreover, virtual reality programs are designed to be more entertaining and sustainable for a long time compared to traditional treatment programs. There are no virtual reality devices specially designed for treatment, but the game consoles used in the market are modified for this purpose and used comfortably.
Oculus rift is a console that can create a real virtual reality environment. The individual has a realistic experience by seeing his own avatar and interacting with objects in a world where he will be 360-degree interactive in a designed environment completely isolated from the external environment. It is the most advanced technology of virtual reality applications used today, and it increases the individual's feeling of being in a 3D environment with glasses that use the entire visual field of the person and headphones for the transmission of sounds.
As an alternative treatment approach, mirror therapy has been suggested to be beneficial. Unlike other interventions that use somatosensory input to aid motor recovery, mirror therapy relies on visual stimulation. During mirror therapy, a mirror is placed in the patient's midsagittal plane so that the nonparetic side is mirrored as if it were the affected side. The advantages of mirror therapy are that it is relatively easy to administer and can be self-administered, even for patients with severe motor deficits.
Mirror therapy is claimed to alleviate post-stroke hemiparesis. Studies confirm the positive effects of mirror therapy on patients' mobility in post-stroke upper extremity hemiparesis. The concept of mirror therapy is explained neurophysiologically. Evidence suggests that the same cortical motor areas that are active during the observation of movements are involved in the performance of observed actions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The assessor will not know which group the patients are in. Participants in control group will experience a virtual reality environment without any interaction
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a ischemic stroke
- •Stroke duration not less than 2 months and not more than 6 months
- •Individuals with a score of 2b and 3 according to the Thrombolysis in cerebral infarction (TICI) scale
- •A score of 2 and above according to the upper extremity motor assessment of the NIH stroke scale
- •Intact depth perception in the Titmus Stereopsis assessment
- •A score of 24 and above in the Mini-mental test and
- •Independent sitting balance
排除标准
- •Additional neurologic diseases
- •Have a head injury
- •Have a brain tumor
- •Prior cranial surgery
- •Psychological disorder or mental problem
- •Previous stroke
- •Aphasia and apraxia
- •Upper extremity amputation
研究组 & 干预措施
VR group
During the exercise, games will be selected from the movements that focus on upper extremity function and require the use of both extremities. These functions will be to grasp the object with both hands, to throw the object, and to provide the object's rotation by revealing the hand's supination-pronation movement. During these movements, the image of the healthy side will be mirrored to the affected side. Before each exercise, what kind of movement requested from the patient will be shown in the VR environment.
干预措施: Virtual reality applications based on mirror therapy (Other)
VR group
During the exercise, games will be selected from the movements that focus on upper extremity function and require the use of both extremities. These functions will be to grasp the object with both hands, to throw the object, and to provide the object's rotation by revealing the hand's supination-pronation movement. During these movements, the image of the healthy side will be mirrored to the affected side. Before each exercise, what kind of movement requested from the patient will be shown in the VR environment.
干预措施: Conventional treatment (Other)
Control group
In addition to mirror therapy, Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facilitation techniques, which are traditional physical therapy and rehabilitation methods, will be applied to the control group. In addition, a virtual environment monitoring session will be conducted in non-interactive virtual environments for 10 minutes after their treatment.
干预措施: Conventional treatment (Other)
Control group
In addition to mirror therapy, Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facilitation techniques, which are traditional physical therapy and rehabilitation methods, will be applied to the control group. In addition, a virtual environment monitoring session will be conducted in non-interactive virtual environments for 10 minutes after their treatment.
干预措施: Mirror therapy (Other)
Control group
In addition to mirror therapy, Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facilitation techniques, which are traditional physical therapy and rehabilitation methods, will be applied to the control group. In addition, a virtual environment monitoring session will be conducted in non-interactive virtual environments for 10 minutes after their treatment.
干预措施: Placebo virtual reality (Other)
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: 8 Weeks
It is a scale based on measuring upper extremity performance in stroke patients. Test; reflex activity, flexor and extensor synergy, combined synergistic movements, non-synergy movements, normal reflex activity, wrist and hand evaluation, coordination and speed evaluation subsections. It consists of 33 items in total, and each item is scored between 0 and 2 points (0: unable, 1: partially able, 2: fully able). The total score is 66.
次要结局
- Simulator Sickness Questionnaire(8 Weeks)
- Evaluation of Cortical Activation with EEG(8 Weeks)
- System Usability Scale(8 Weeks)
- Motor Activity Log-28(8 Weeks)
- Stroke-Specific Quality of Life Scale(8 Weeks)
研究者
Ramazan KURUL
Assistant Professor
Abant Izzet Baysal University