Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number or participants finishing the trial
研究概览
简要总结
Stroke is one of the leading causes of disability and death in North America and Europe. Up to 30% of stroke survivors never recuperate completely and suffer from loss of function and poor quality of life. To improve recovery after stroke, innovative interventions should be a priority.
Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere (ATA). There is a growing body of evidence that HBOT can enhance ability of brain to changes its structure (neuroplasticity) in order to recover. Exercise program during HBOT can augment the effect. Although, recent randomized controlled trials in patients with chronic brain injury showed promising results, there are no studies demonstrating combine effect HBOT and exercise rehabilitation program on stroke recovery.
The proposed study investigates feasibility, safety and efficacy of using a combination of HBOT and exercise program to improve arm function recovery in chronic stroke patients. In this pilot randomized control trial, investigators will compare the combination of HBOT and the focused rehabilitation exercise program versus exercise program alone on recovery of arm function in patients with chronic stroke.
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
- 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
- •age > 18 years
- •history of ischemic or hemorrhagic stroke 6-48 months confirmed by CT
- •arm hemiparesis/hemiplegia
- •Chedoke-McMaster Stroke Assessment Scale 3-6
- •ability to follow verbal commands
排除标准
- •women with positive pregnancy test or plans to become pregnant during the study period
- •severe cognitive dysfunction (The Mini Mental State Examination <24 )
- •claustrophobia
- •seizure disorder
- •active asthma
- •severe chronic obstructive pulmonary disease
- •history of spontaneous pneumothorax
- •history of severe congestive heart failure with left ventricular ejection fraction < 30%; unstable angina
- •myocardial infarction (within the last 3 months)
- •chronic sinusitis
- •chronic acute otitis media or major ear drum trauma
- •current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
- •participation in another investigative drug or device trial currently or within the last 30 days
结局指标
主要结局
Number or participants finishing the trial
时间窗: 8 weeks
The number of patients finishing the trial
次要结局
- Total time spent doing rehabilitation exercise(8 weeks)
研究者
Jo Carroll
Manager Anesthesia Research
University Health Network, Toronto