Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Rivermead mobility index (RMI) at 6 weeks
研究概览
简要总结
Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.
详细描述
10 patients having suffered a stroke and having being rehabilitated will be treated with 40 consecutive Hyperbaric Oxygen Treatment (HBOT) after a minimal delay of 3 months after stroke. They will be neurologically assessed before and 3 months after HBOT. Rivermead mobility index will be also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with ischemic cortical stroke in chronic stage (≥ 3 months) with residual motor deficits confirmed by imaging with brain CT scan and/or brain MRI
- •Informed consent
排除标准
- •Neurological issue:
- •inability to understand the informed consent form
- •Hemiplegia
- •Hyperbaric issue:
- •Claustrophobia
- •inability to put on face mask
- •uncontrolled epilepsy
- •dementia or psychological disturbance
- •previous pneumothorax
- •pregnancy
研究组 & 干预措施
Stroke patients
40 consecutive sessions of hyperbaric oxygen will be administered at a pressure of 2 absolute atmosphere (ATA) to 10 patients. If there are drop outs, recruitment will be continued until a total of 10 patients with at least 30 sessions.
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
Change in Rivermead mobility index (RMI) at 6 weeks
时间窗: Change from Baseline RMI at 6 weeks
Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
Change in Rivermead mobility index (RMI) at 1 month
时间窗: Change from Baseline RMI at 1 month
Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
Change in National Institutes of Health Stroke Scale (NIHSS score)
时间窗: Change from Baseline NIHSS Score at 3 months
Neurological assessment before and after HBOT. Composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 (0 is better).
Change in Rivermead mobility index (RMI) at 3 months
时间窗: Change from Baseline RMI at 3 months
Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
Change in Rivermead mobility index (RMI) at 2 weeks
时间窗: Change from Baseline RMI at 2 weeks
Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
Change in Rivermead mobility index (RMI) at 8 weeks
时间窗: Change from Baseline RMI at 8 weeks
Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
Change in Rivermead mobility index (RMI) at 4 weeks
时间窗: Change from Baseline RMI at 4 weeks
Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
次要结局
- Change in Visual Acuity(Change from Baseline Visual Acuity at 3 months)
- Tympanic damage(From date of Start of HBOT until the date of End of HBOT)