Comparison of the Effects of Mirror Therapy,Repetitive Transcranial Magnetic Stimulation and Robotic-assisted Hand Therapy Added to Neurological Rehabilitation on Upper Extremity Functions, Quality of Life and Pain in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Fugl Meyer Upper Extremity Assessment Questionnaire
研究概览
简要总结
The aim of the study is to investigate the comparison of the effects of mirror therapy, Repetitive Transcranial Magnetic Stimulation and robot-assisted hand therapy added to conventional neurological rehabilitation on upper extremity function, quality of life and pain in stroke.
详细描述
Stroke is the second leading cause of death in adults and an important cause of long term disability. Functional limitations that develop in the post stroke period affect participants quality of life and activities of daily living. Today, despite advances in rehabilitation and new pharmacologic strategies, stroke related upper extremity function, quality of life and pain treatment may not always achieve the desired results. There are new approaches in stroke rehabilitation such as mirror therapy, Repetitive Transcranial Magnetic Stimulation, robot-assisted hand therapy. Three groups will take part in this study. All three groups will receive a total of 20 sessions of conventional neurological rehabilitation program 5 days a week for 4 weeks. In addition to the first group, a total of 20 sessions of upper extremity mirror therapy program will be applied for 4 weeks, 5 sessions per week. The second group will receive Repetitive Transcranial Magnetic Stimulation (rTMS) to the contralateral M1 upper extremity motor cortex region at low frequency (1Hz) and at an intensity of 100%-110 of the resting motor threshold, 5 sessions per week for a total of 20 sessions for 4 weeks. The third group will receive a total of 20 sessions of robot-assisted hand therapy using AMADEO (Tyromotion Austria) 5 days a week for 4 weeks.These three groups will be compared in terms of upper extremity function, quality of life and pain.Brunstroom, Mini Mental Test, Modified Ashworth Scale, Fugl Meyer Upper Extremity Motor Assessment Scale, Box Block Test, Nine Hole Pag Test, ABILHAND Stroke Hand Function Questionnaire, Stroke Impact Questionnaire, Stroke Specific Quality of Life Scale, Visual Analog Scale , LANNS neuropathic pain assessment scale, 4 Question Neuropathic Pain Questionnaire, Beck Depression Inventory, Beck Anxiety Scale, Pittsburgh Sleep Quality Index, MEP (motor evoked potential) measurement will be done . Participants will be evaluated by a physician twice at the beginning and at the end of treatment (4th week).
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
Participants and intervention providers were not blinded because of the distinct nature of the interventions. Investigators and outcome assessors remained blinded to treatment allocation until completion of all outcome assessments. Personnel administering the interventions were not involved in participant assessment or outcome evaluation.
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
- •Patients who applied to Afyonkarahisar Health Sciences University Hospital Physical Medicine and Rehabilitation Polyclinic with the diagnosis of hemiplegia after a cerebrovascular accident in the inpatient ward or as an outpatient for neurological rehabilitation after taking the anamnesis and physical examination, who met the inclusion criteria and eliminated the
排除标准
- •Female and male patients between the ages of 40-80
- •stroke at least 3 months ago
- •voluntarily agreed to participate in the study regularly, whose health status is suitable for rehabilitation and who are medically stable
- •mini mental test score of 15 and above
- •Neurologically stable patient
- •Exclusion Criteria:
- •significant comorbidities such as serious heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension
- •history of epilepsy, antiepileptic drug use
- •intracranial metal objects
- •intraauricular implants
- •cognitive dysfunction
- •upper extremity peripheral nerve injuries
- •malignancy
- •active infection
- •skin infections or open wounds in the application area
- •inflammatory diseases
- •orthopedic injuries that may limit maximum effort capacity
- •brain lesion or drug use history that may affect the seizure threshold
- •increased intracranial pressure
- •uncontrolled migraine
- •severe spasticity in the hand (MAS≥3)
- •contracture in the hand
- •have had a fracture or surgery on the hemiplegic side in the last 6 months
- •severe visual impairment
- •severe depression
结局指标
主要结局
Fugl Meyer Upper Extremity Assessment Questionnaire
时间窗: Baseline and Post-treatment (4th week)
The Fugl Meyer Upper Extremity Motor Assessment Scale was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's stages of motor recovery. The FMUE Scale consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66. A range of data is available for the minimum clinically important differences for the FMUE Scale. A change of 4 to 7 points in chronic stroke, 12 points in subacute stroke, and 9 to 10 points is considered clinically significant.Higher scores indicate better upper limb functional recovery.
次要结局
- Brunnstrom Staging(Baseline and Post-treatment (4th week))
- Mini Mental Test(Baseline)
- Modified Ashworth Scale(Baseline and Post-treatment (4th week))
- Box Block Test(Baseline and Post-treatment (4th week))
- Nine Hole Peg Test(Baseline and Post-treatment (4th week))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and Post-treatment (4th week))
- ABILHAND Stroke Hand Function Questionnaire(Baseline and Post-treatment (4th week))
- Stroke Impact Scale(Baseline and Post-treatment (4th week))
- Stroke Specific Quality of Life Scale(Baseline and Post-treatment (4th week))
- The Self Assessment of Neuropathic Symptoms and Signs (S-LANSS)(Baseline and Post-treatment (4th week))
- Beck Depression Scale(Baseline and Post-treatment (4th week))
- Beck Anxiety Inventory(Baseline and Post-treatment (4th week))
- Neuropathic Pain Questionnaire in 4 Questions(Baseline and Post-treatment (4th week))
- Visual Analog Scale (VAS)(Baseline and Post-treatment (4th week))
- Neurophysiological Measurements(Baseline and Post-treatment (4th week))
研究者
Selma Eroğlu
Associate Professor
Afyonkarahisar Health Sciences University