Effects of Robot-assisted Arm Training on Respiratory Muscle Strength, Activities of Daily Living and Quality of Life in Stroke Patients: A Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of baseline maximum inspiratory pressure
研究概览
简要总结
Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately cause respiratory and functional limitation. Respiratory muscle weakness including the diaphragm leads to biomechanical change in respiration which can reduce vital capacity and total lung capacity of stroke patients. The weakness of diaphragm and abdominal muscle also leads to decrease in maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in stroke patients.
Respiratory muscle training such as inspiratory or expiratory muscle training is commonly used to improve the respiratory muscle strength and function in stroke. However, it was reported that respiration is closely related to upper limb function because the muscle of upper extremities surrounds the dorsal muscle of trunk and in order to breath, the movement of trunk is necessary, which in turn is related to the movement of the upper limbs.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 year and above
- •Acute and sub-acute stroke patients
- •had MIP values lower than 70% of those predicted when adjusted for age and sex,
- •had no facial palsy, aphasia, or dysarthria, which would prevent respiratory muscle strength testing
- •Ischemic or Hemorrhagic stroke
- •No medical history of respiratory or lung disease
排除标准
- •patients with increased intracranial pressure, uncontrolled hypertension, decompensated heart failure, unstable angina, recent myocardial infarction, complicated arrhythmias, pneumothorax, bullae/blebs in the preceding 3 months
- •Any pulmonary or lungs disease
- •Any neurological conditions other than stroke
- •Using medications that could interfere with neuromuscular control or cause drowsiness.
- •Severe cognitive function (Mini-Mental Test result <24)
- •Chronic stroke
- •Recurrent stroke, brain stem stroke, and aphasia were excluded.
结局指标
主要结局
Change of baseline maximum inspiratory pressure
时间窗: Baseline, Post-intervention ( 6 weeks)
Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.
Change of baseline maximum expiratory pressure
时间窗: Baseline, Post-intervention ( 6 weeks)
Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.
Change from baseline ABILHAND
时间窗: Baseline, Post-intervention ( 6 weeks)
A questionnaire to assess active function of the upper limbs with 23 activities, rated as impossible, difficult or easy. The scale is scored through Rasch analysis, providing a total score ranging from -6 to +6, with higher scores indicating a lower degree of upper extremity impairment.
次要结局
- Change from baseline Stroke Impact Scale(Baseline, Post-intervention ( 6 weeks))
研究者
Ishtiaq Ahmed
Principal Investigator
Istanbul University - Cerrahpasa (IUC)