The Effects of a Task Based Computerised Exercise System Versus Conventional Physiotherapy on Upper Extremity Functionality, Cognitive Function and Quality of Life in the Rehabilitation of Stroke Patients: a Randomised Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in upper extremity impairment
研究概览
简要总结
Stroke occurs as a result of blood vessels of the brain becoming blocked or bleeding which in turn can result in loss of function in the limbs. Rehabilitation of patients following stroke includes repetitive, task based exercises to help regain normal limb function. Developments in stroke rehabilitation have resulted in more and more therapeutic options being available for inclusion in the treatment plan of stroke patients. The benefits of computerised task based arm and hand rehabilitation exercises in stroke rehabilitation are well known. Computer based rehabilitation supports the stroke patient in performing high intensity, multiple repetition exercises and in doing so encourages the regeneration of brain cells. In addition, it is believed that the stimulating environment provided by computerised exercise programs encourages the ability to problem solve and perform tasks. However, the effects of such computer based treatments on cognition have rarely been studied.
In Turkey to date there are no community based, task specific computerised exercise programmes available to stroke sufferers. Such systems may provide inpatient and community based stroke sufferers with a practical and economical therapeutic option as a part of stroke rehabilitation. Moreover, this may provide the patient with a mode of ongoing, long term therapeutic exercise and maintenance of skills acquired in the hospital rehabilitation period shortly after stroke.
The aim of this study was to investigate the benefits of computer based, task specific exercises when compared to conventional rehabilitation alone on arm and hand function, quality of life and cognition in stroke patients.
详细描述
In developed countries only 5-10% of chronic stroke patients receive an active rehabilitation program. In Turkey, there is no community based rehabilitation program available to stroke patients in the subacute - chronic phase of the disease, even though it is known that functional gain can continue in this part of the disease when supported by an adequate rehabilitation program. Equally, functional gain can be lost over time if appropriate physical therapy is discontinued.
Recent Advances in technology have allowed for the development of new approaches in stroke rehabilitation. Computer based treatment options include virtual reality (VR), robotic training and computer based task specific games. Computer based rehabilitation can encourage patients in performing high intensity, repetitive exercises which in turn aids neuroplasticity; the benefits of such treatments in upper extremity rehabilitation following stroke have been established. It is also believed that the stimulating environment provided by computed based exercises can enhance the development of problem solving and functionality in stroke patients. However, the effects of such technology on cognitive function in stroke patients has not been established in the literature. The disadvantages of VR and robotic training is that the necessary hard and software is often expensive and use of the machinery requires special training. Therefore, these options are often unavailable in rehabilitation centres. Contrary to this, computerized task specific gaming systems can be more economical and practical for both therapist and patient and can be used in the home environment without the necessity of direct supervision of a physiatrist.
A review by Johansson et al. on home computer based task specific gaming exercises in stroke patients concluded that patients enjoyed the treatment but determining the benefits of treatment require further randomized control studies of better quality to be conducted. A pilot study based on a six week computer based task specific gaming exercise program in chronic stroke patients resulted in an improvement in learnt tasks and clinical evaluation.
Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.
The aim of this study was to study the effects of computer game based task specific exercise system on upper extremity and hand function as well as cognitive function and quality of life compared to conventional rehabilitation in stroke patients.
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 (Investigator, Outcomes Assessor)
盲法说明
The primary investigator will be blind to the treatment received by the patients and will carry out all patient evaluations before and after the treatment program is completed.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-80 years
- •Admitted to our PRM Department with a diagnosis of hemiplegia secondary to stroke for rehabilitation
- •Upper extremity and hand Brunnstrom staging of ≥
- •MMSE score of ≥23.
排除标准
- •Presence of disability of the arms and hand which affects upper extremity motor function prior to stroke
- •Presence of diplegia
- •Presence of neglect
- •Presence of visual field defect
- •Presence of loss of hearing
- •Presence of spasticity in the hemiplegic upper extremity and hand of grade 3 and above according to the Modified Ashworth Scale
- •Presence of acute musculoskeletal pain which will affect exercise participation
- •Inability to sit upright in a chair for 30 minutes.
- •Those who are clinically unstable due to comorbidities.
结局指标
主要结局
Change in upper extremity impairment
时间窗: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.
次要结局
- Mini mental state examination (MMSE)(Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).)
- Change in motor activity(Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).)
- Stroke Specific Quality of Life (SS-QOL) Scale(Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).)
- Montreal Cognitive Assessment (MoCA) test(Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).)
研究者
Selin Ozen
Physical and Rehabilitation Medicine Specialist
Baskent University