Evaluation of the Effectiveness of Virtual Reality-Based Upper Extremity Rehabilitation in Patients With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assisting Hand Assessment (AHA)
研究概览
简要总结
Cerebral palsy (CP) refers to a group of permanent disorders that occur in the brain of the fetus or infant, which are non-progressive, cause movement and posture disorder along with activity limitation.
The upper extremity is frequently affected in patients with CP. The prevalence of upper extremity involvement has been reported between 60-83% in different studies.
Virtual reality applications have been increasing recently in the field of neurological rehabilitation. In this study, researchers aimed to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation in patients with hemiplegic cerebral palsy.
详细描述
Cerebral Palsy (CP) is a group of permanent disorders of movement and posture development due to non-progressive damage to the developing fetal or infant brain, causing activity limitation. Motor disorders in CP are mostly accompanied by sensory and perceptual problems, cognitive disorders, communicative and perceptual problems, epilepsy and secondary musculoskeletal problems. CP is one of the most common causes of disability in childhood. Brain damage that causes CP can occur in the prenatal, perinatal or postnatal period. Accompanying epilepsy, cognitive disorders, learning impairment, communication problems, perception limitation, behavioral problems, visual disturbances, hearing disorders, oral motor function problems, dysphagia, constipation, gastroesophageal reflux disease, dental problems, urinary symptoms, osteoporosis can be seen in patients with CP.
Technologies that are developing in rehabilitation are increasingly being used. Among these technologies, the use of virtual reality by trained physiatrists and physiotherapists provides an environment where children with cerebral palsy can exercise. In addition to intense exercise, simultaneous visual and auditory feedback can be received. Virtual reality can also provide a comparison between the degree of movement children perform in the real world and the degree of movements they observe in the virtual environment. All these features make virtual reality a potentially viable tool for improving the motor skills of children with CP.
Virtual reality-based rehabilitation is an emerging treatment modality for the motor rehabilitation of children with cerebral palsy. Neuroplasticity studies have shown that neurological development is positively associated with active participation and motivation during virtual reality-based rehabilitation intervention. In addition to motivation, virtual therapy also improves neural reorganization that optimizes rehabilitation outcomes in children with cerebral palsy. The virtual scenario seems to encourage motor learning, the retention of learned skills, and the transfer of skills to real-world situations. In many studies, improvement in posture, balance, upper extremity functions, joint control and walking has been detected with virtual therapy. Increased 'biofeedbacks' in neuromotor rehabilitation allowed therapists to methodologically design and control their intervention strategies.
40 patients with a diagnosis of Cerebral Palsy who applied to the Pediatric Rehabilitation Unit of Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, who meet the inclusion criteria will be included in this randomized, controlled, single blind and prospectively planned study. At the beginning of the study, 40 hemiplegic CP patients who meet the inclusion criteria will be randomized into two groups according to the random order created by the computer program after being numbered according to the order of application to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Pediatric Rehabilitation Unit. Upper extremity rehabilitation (bimanually 3 days a week for 6 weeks and 45 minutes per session) and physiotherapy (TG: Treatment Group) will be given to the first group accompanied by virtual reality, and only physiotherapy (CG: Control Group) will be given to the second group.
When the power analysis was performed to calculate the number of patients and when the results obtained from other studies were taken into account, it was concluded that at least 18 patients should be included in each group to obtain 0.95 power at 95% confidence interval. Considering that few people will be excluded from the study during the study, it was found appropriate to include 20 patients in each group and to start the study with a total of 40 people. Before starting the study, the patients will be informed about the study and their consent will be obtained and demographic characteristics such as age, height and weight will be evaluated.
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
- Single (Outcomes Assessor)
盲法说明
Assisting Hand Assessment was planned to be used in the evaluation of upper extremity functions as the primary outcome assessment tool. The person making this assessment will be blind to the study groups.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with hemiplegic CP by a specialist pediatric neurologist,
- •Being between the ages of 5-12,
- •Following the child's simple commands and participating in the given tasks,
- •Being at the Gross Motor Function Classification System (KMFSS) Stage 1, 2 or 3,
- •Being in Hand Skills Classification System (MACS) Stage 1, 2 or 3,
- •Mild / moderate muscle tone; Modified Ashworth Scale level 1-2 and Tardieu Scale level 1-2,
- •Parents agree to participate in the intensive treatment program and to cease all other upper extremity therapeutic interventions during the 3-month follow-up period.
排除标准
- •Having uncontrollable epileptic seizures
- •Significant contractures in the fingers, wrists, elbows and shoulders that prevent daily activities,
- •Having serious vision and hearing problems,
- •Cognitive impairments that prevent understanding and performing simple commands and tasks,
- •Not being able to continue the treatment protocol due to the school program,
- •Current or previous treatments that are not compatible with the treatment protocol of the study,
- •Orthopedic surgery (tendon transfer / tendon lengthening) applied to the upper extremity,
- •Receiving upper extremity treatment within the last 6 months (BTX-A or orthopedic interventions),
- •Uncontrolled disease (endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal), active systemic inflammatory disease and / or history of malignancy
研究组 & 干预措施
Virtual Reality Group
To the virtual reality group; In addition to upper extremity exercises applied 2 days a week, upper extremity rehabilitation via virtual reality glasses will be performed 3 days a week for 6 weeks and each session will be 45 minutes.
干预措施: Virtual reality mediated upper extremity rehabilitation (Other)
Virtual Reality Group
To the virtual reality group; In addition to upper extremity exercises applied 2 days a week, upper extremity rehabilitation via virtual reality glasses will be performed 3 days a week for 6 weeks and each session will be 45 minutes.
干预措施: Classical exercise therapy for upper extremities (Other)
Control Group
Upper extremity exercises will be applied to the participants in the control group 2 days a week for 6 weeks.
干预措施: Classical exercise therapy for upper extremities (Other)
结局指标
主要结局
Assisting Hand Assessment (AHA)
时间窗: 12 weeks
AHA is a test that measures how patients with impaired upper extremity functions, such as hemiplegic CP or congenital brachial plexus injury, use the affected hand together with the healthy hand when playing with both hands. The AHA 5.0 version consists of 20 items that evaluate hand functions, and the raw score range is between 20 and 80 points. Higher scores indicate better hand function.
次要结局
- Modified Ashworth Scale(12 weeks)
- Tardieu Scale(12 weeks)
- QUEST(12 weeks)
- Joint Range of Motion Measurement(12 weeks)
- ABILHAND-Kids(12 weeks)
- KINDL(12 weeks)
研究者
Ahmet Kivanc Menekseoglu
Principal Investigator
Istanbul University