Effects of Electromechanical-assisted Gait Training Within an Integrated, Practice-oriented Therapy Approach in Subacute Stroke Patients - a Randomised Controlled (RCT) Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Competence in basic ADL (ICF-level activity):
研究概览
简要总结
Background and Rationale:
Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious rehabilitation programs 70% of those stroke patients still show limited gait ability after three months.
Numerous RCTs have shown the superiority of over ground gait training and electromechanical-assisted gait devices in comparison with conventional over ground gait training alone. (Jan Mehrholz, Elsner, Werner, Kugler, & Pohl, 2013) However, most of these trials used the electromechanical-assisted gait devices in a very high frequency which is almost impossible to achieve in daily clinical routine. Therefore, the effect of a practice-oriented physical therapy protocol including electromechanical-assisted gait training remains unclear.
Objective(s):
The aim of this clinical trial is to investigate the effects of an integrated, practice-orientated individual physical therapy protocol with or without electromechanical-assisted gait training in subacute stroke patients, respectively.
The effects of both physical therapy protocols will be compared with validated assessments covering the different components of the ICF framework: function, activity and participation.
Primary objectives: Effects on gait ability and on basic activities of daily living (ADL).
Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle force, spasticity and reintegration to normal living (RNLI).
Furthermore, different training-related data are recorded to capture the efficiency (intensity and hassle) of both physical therapy protocols.
详细描述
Background and Rationale:
Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious rehabilitation programs 70% of those stroke patients still show limited gait ability after three months.
Numerous RCTs have shown the superiority of over ground gait training and electromechanical-assisted gait devices in comparison with conventional over ground gait training alone. (Jan Mehrholz, Elsner, Werner, Kugler, & Pohl, 2013) However, most of these trials used the electromechanical-assisted gait devices in a very high frequency which is almost impossible to achieve in daily clinical routine. Therefore, the effect of a practice-oriented physical therapy protocol including electromechanical-assisted gait training remains unclear.
Objective(s):
The aim of this clinical trial is to investigate the effects of an integrated, practice-orientated individual physical therapy protocol with or without electromechanical-assisted gait training in subacute stroke patients, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only assessors of the primary outcomes will be blinded to group assignment
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
- •age: 18- 80 years
- •diagnosis: first-time supratentorial stroke (ischaemic/haemorrhagic)
- •time after stroke (at admission): <42 days
- •not able to walk independently (FAC 0-2)
- •able to sit unsupported without holding (but with floor contact) on the edge of the bed for at least 2min
- •written informed consent
排除标准
- •hip, knee, ankle arthrodesis
- •bone instability (non-consolidated fractures, unstable spina column, severe osteoporosis)
- •unstable vital functions, e.g. cardio-vascular or pulmonary functions
- •severe impaired consciousness functions (ICF b110)
- •severe vascular disorders of the lower limb
- •severe cognitive deficits (not able to understand and follow test instructions and/or training protocol)
- •severely fixed contractures
- •mechanical ventilation
- •open skin lesions in the area of the torso
- •patients with extremly disproportionate growth of legs and/or spinal column (e.g. bone or cartilage dysplasie)
- •patients with acute infection
- •body weight > 150kg
研究组 & 干预措施
Experimental group (EG)
Subacute stroke patients will get standard individual physical therapy 2x/week, 45min and electromechanical-assisted gait training on LYRA® gait trainer 3x/week, 45min.
干预措施: LYRA® gait trainer (Device)
Comparator group (CG)
The CG will get standard individual physical therapy 5x/week, 45min without any instrument-based locomotion therapy (i.e. treadmill training, electromechanical/robot-assisted gait training).
干预措施: Standard individual physical therapy (Device)
结局指标
主要结局
Competence in basic ADL (ICF-level activity):
时间窗: T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion; T3: 3 month after intervention end
To assess change in competence in basic ADL the functional Independence measure (FIM) is performed. To assess change over time the FIM will be assessed three times: before Intervention, immediately after Intervention and 3 months after Intervention.
Gait ability (ICF-level activity)
时间窗: T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion; T3: 3 month after intervention end
To assess change in gait ability the FAC is performed. The FAC is technically simple, inexpensive, reliable and sensitive to change in the assessment of patients after stroke who cannot walk without personal assistance at the beginning of their inpatient rehabilitation. The FAC provides information about the way of physical (not technical e.g. walking aids, orthosis) assistance that is needed for walking. To assess Change over time the FAC will be assessed three times: before Intervention, immediately after Intervention and 3 months after Intervention.
次要结局
- Walking speed (ICF-level activity):(T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion)
- Functional Mobility (ICF-level activity):(T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion)
- Walking capacity (ICF-level activity):(T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion)
- Muscular Strength lower extremities (ICF-level structure/function):(T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion)
- Spasticity (ICF-level structure/function):(T1: 2-4 days after study inclusion; T2: 30-32 days after study inclusion)
- Reintegration to normal living (ICF-level participation):(3 month after intervention end)