Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- The Stroke Rehabilitation Assessment of Movement Scale
研究概览
简要总结
Early term rehabilitation initiated after stroke should be based on motor learning principles and neural plasticity. To achieve motor learning and neural plasticity, exercises consisting of intense and repetitive training should be given according to the patients' functional level. The neurodevelopmental treatment-Bobath (NDT_B) approach is based on motor learning principles. In literature, studies that show the early term effects of NDT-B on functional recovery are inadequate. The aim of this study was to investigate the effects NDT-B applied in the early term of stroke, on postural control, functional movement, balance and activities of daily living.
详细描述
When literature is examined, it can be seen that evidence is limited. Studies investigating the effects of the Bobath Approach in the early term in stroke, state that NDT-B is reliable and feasible. However none of these studies have examined the effects of NDT-B in acute term stroke on functionality and daily living. Additionally, in all of these studies it was also stated that further studies should be conducted.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients older than 18 years of age
- •Systolic blood pressure between 120 and 220 mmHg
- •Oxygen saturation >92% (with or without O2 support)
- •A heart rate of 40 to 100 beats/min
- •A body temperature of <38.5°C
- •A disability level of ≤4 according to the Modified Rankin Scale
- •Those who could respond to verbal commands
排除标准
- •A history of previous stroke
- •Concomitant progressive neurological disturbances
- •Acute coronary disease
- •Severe heart failure
- •Concomitant rheumatologic diseases
- •A fracture or an acute orthopedic disorder that would prevent mobilization
研究组 & 干预措施
Neurodevelopmental Therapy-Bobath group
Bobath Approach Principles and exercises will be performed 5 days a week with physical therapists and everyday with caregivers. Physiotherapy will be initiated as early as possible according to the principles of the method by experienced NDT-B therapists. Exercises will be implemented according to the patients' status and will be used to maintain and improve muscle strength and endurance. Both the unaffected and affected side will be included in rehabilitation. The exercises given are designed to be simple, understandable, task-oriented and repetitive, in accordance with the Bobath approach and the functional state of the patient at that time. In order to prevent motor amnesia and neglect of the affected side, correct positioning and sensory input will be provided since the first session.
干预措施: Neurodevelopmental Therapy-Bobath group (Other)
Standart Rehabilitation Group (SR group)
Patients will be included in standard rehabilitation sessions, 5 days per week. The rehabilitation sessions will be performed by standard clinical physiotherapists according to the hospital routine. The rehabilitation program will consist of in-bed joint range of motion exercises and bedside mobilization applications. The patients will be included in the rehabilitation program as early as possible and the program will continue until the patients are discharged
干预措施: Standart Rehabilitation Group (SR group) (Other)
结局指标
主要结局
The Stroke Rehabilitation Assessment of Movement Scale
时间窗: Change from Baseline functional movements at 10 days
The Stroke Rehabilitation Assessment of Movement Scale (STREAM) was used to assess functional movements and mobility. The scale consists of two subsections and a total of 30 tests evaluating the performance and the quality of the individual's voluntary limb movements (20 tests) and basic mobility activities (10 tests). The total score will be used for assessment in this study. The total score is 70. A high score indicates less motor impairment, while a lower score indicates increased motor impairment.
次要结局
- The Berg Balance Scale(Change from Baseline functional balance at 10 days)
- The Functional Ambulation Classification(Change from Baseline level of functional ambulance at 10 days)
- The Trunk Impairment scale(Change from Baseline sitting balance and postural control at 10 days)
研究者
Gokhan Yazici
Principal Investigator
Gazi University