Robot-assisted Locomotor and Stair Climbing Training for Improving Mobility and Participation in Daily Activities in Persons Affected by Stroke: a Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- The time required to climb Up and Down 9 stairs (seconds)
研究概览
简要总结
Stair climbing up and down is an essential part of everyday's mobility. Physiotherapy is focused on muscle strengthening, real floor walking and stairs climbing tasks, but these methods do not stress in terms of intensity stair-climbing practice. The aims of this study is to compare whether an intensive robot-assisted stair climbing training (RASCT) is more effective than conventional physiotherapy (CP) for improving stair climbing ability, gait and postural control in stroke patients.
详细描述
Trial design: A pilot randomized (allocation ratio 1:1), single blind clinical trial (RCT) comparing the effects between the experimental [Robot-Assisted Stair Climbing Training group (RASCT)] and control group (Conventional Physiotherapy, CP) in improving stair climbing ability and postural control in stroke patients. The examiner will be blind to group assignment.
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
- •First-ever ischemic or hemorrhagic stroke;
- •More than or equal to 3 months post stroke;
- •Age>18 years;
- •Mini- Mental State Examination (MMSE) score more than 23;
- •Ability to stand for at least 1 min without arm support; ability to walk independently for at least 10 m with or without walking aids;
- •Functional Ambulation Category score equal or more than
- •Signed informed consent form
排除标准
- •Severe cognitive or communicative disorders that hamper collaboration;
- •Unstable cardiovascular system conditions (i.e. labile compensated cardiac insufficiency, angina pectoris), deep vein thrombosis, severe neurological or orthopedic diseases which massively affect lower limb mobility; severe joint misalignment;
- •Treatment of lower limb spasticity (i.e. botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.
研究组 & 干预措施
Robot-Assisted Stair Climbing Training
Each session will consist of the G-EO System training and stretching exercises. Total net treatment time/session: 50 minutes. Physiotherapists will alter constraints to grade tasks according to patient ability. The training complexity will be increased, as the patient will improve in performance (i.e. increasing gait speed, reducing body weight support, increasing the number of repetition). Heart rate during training sessions will be monitored using a Polar V800. Heart rate will not exceed the threshold of 120 bpm.
干预措施: G-EO System (Device)
Conventional Physiotherapy
50 min of overground walking training and stair climbing up/down and lower limb mobilization and stretching exercise.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
The time required to climb Up and Down 9 stairs (seconds)
时间窗: 1 day
(seconds)
次要结局
- 6-Minute Walking Test evaluates walking endurance.(1 day)
- Fatigue Severity Scale(1 day)
- Barthel Index(1 day)
- EMG gait(1 day)
- The Timed Up and Go test evaluates person's mobility.(1 day)
- The Modified Ashworth Scale evaluates muscle spasticity.(1 day)
- Borg Scale(1 day)
- Stabilometric assessment(1 day)
- The 10-Meter Walking Test evaluates gait speed.(1 day)
- Functional Ambulation Category (FAC);(1 day)
- Dynamic Gait Index (DGI)(1 day)
- European Stroke Scale(1 day)
- Blood pressure(1 day)
- The Berg Balance Scale evaluates standing balance during functional activities.(1 day)
- Number of steps performed with the Robot and without.(1 day)
- heart beat(1 day)
研究者
Nicola Smania, MD, Clinical Professor
Professor of Rehabilitation Medicine
Universita di Verona