Improvement of Postural Control and Motor Function by Vojta Therapy in Early Stroke Rehabilitation of Stroke Patients - a Pilot Study and New Approach in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital
研究概览
简要总结
Stroke is the major cause for permanent disability in adults. It is still unclear, which physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely used approaches in stroke rehabilitation within the western world, although several studies have failed to demonstrate superiority and showed partially even inferiority compared to other physiotherapy approaches. The Vojta therapy is based on a completely different approach - the reflex locomotion. However to date no study has been performed for stroke. We designed a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to investigate improvement of postural control due to Vojta therapy in early rehabilitation of stroke patients, which is a very new approach in stroke-rehabilitation.
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)
盲法说明
The assessor for the secondary outcome (Barthel Index and mRS after 90 days) is blinded. All other outcome assessors have knowledge of the interventions assigned to individual participants.
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
- •Adult patients (> 18 years)
- •CT or MRI proven acute ischemic (AIS) or hemorrhagic stroke (ICH) within 72h after onset of symptoms
- •Severe hemiparesis (medical research council scale for muscle strength ≤2)
- •premorbid modified Rankin Scale (mRS) ≤3
- •maximal National Institute of Health Stroke Scale Score (NIHSS) 25
- •Voluntary written consent by the patient
排除标准
- •Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
- •Participation on another clinical trial
- •Pregnancy
结局指标
主要结局
Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital
时间窗: Day 1-9 after admission to hospital (+/- 1)
The Trunc Control Test (TCT) is a valid test to asses motor impairment after stroke. A range of 0 to 100 points can be achieved. Patients are tested before the first treatment on day 2, after 5 days and after the last intervention on day 9 (+/-1) after admission to hospital.
次要结局
- Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.(Day 1-9.)
- Improvement of arm motor function measured with the motor evaluation scale for upper extremity in stroke patients [MESUPES, part 1 to 4] on day 9 after admission to the hospital (compared to baseline)(Day 1-9 after hospital admission (+/- 1))
- Improvement of the Barthel Index on day 9 after admission to the hospital(Day 1-9 after hospital admission (+/- 1))
- Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.(Day 1-9.)
- Improvement of neglect measured with the Catherine Bergego Scale (part 5 and 6) after on day 9 after admission to the hospital (compared to baseline)(Day 1-9 after hospital admission (+/- 1))
- Improvement of the Barthel Index on day 90 after stroke onset(Day 90 after stroke onset)
- Improvement of the NIHSS on day 9 after admission to the hospital(Day 1-9 after hospital admission (+/- 1))
- Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset(Day 90 after stroke onset)
研究者
Corina Epple
Principle Investigator
Klinikum Frankfurt Höchst