Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2
研究概览
简要总结
To study safety, feasibility and outcomes of combining osteopathic manipulative therapies with hyperbaric oxygen therapy in reducing the functional deficits in stroke survivors in subacute and chronic phases post ischemic stroke. To document the same as part of a pilot project in anticipation of further investigational studies.
详细描述
The primary objective of this study is to show that hyperbaric oxygen therapy combined with osteopathic manipulative therapies improve outcomes in patients who have persistent neurological deficits after ischemic stroke compared to historical norms.
The secondary objectives of this study is to demonstrate safety and feasibility of treating patients post stroke with hyperbaric oxygen and osteopathic therapies as well as determine improvements in multiple assessment scales of motor function, depression, activities of daily living(ADL) and pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post Ischemic stroke
- •Patients aged 18-80
- •mRS>/=3, which connotes moderate disability requiring some help.
- •Persistent significant motor dysfunction of at least one arm
- •Subacute stroke patients (within three months from time of stroke)
- •Chronic stroke patients (more than 6months from time of stroke)
- •Patient must be able to understand instructions and verbalize discomfort
- •Reliable attendance for daily (M-F) HBOT treatment and 2x/week OMT sessions for up to 6weeks
排除标准
- •Hemorrhagic stroke
- •Prior functional disability mRS >1
- •Expressive or receptive aphasia
- •Bedbound patients due to lifting limitations for HBOT
- •History of severe, advanced emphysema with bullous disease
- •Prior history of spontaneous pneumothorax or chest surgery
- •Prior history of depression requiring medications
- •Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy
- •Significant claustrophobia
结局指标
主要结局
National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2
时间窗: 90 Days
Primary Outcome NIHSS 0-5, 0 without deficits; mRS 0-2, 0 without disability - 2 slight disability, no need for assistance
次要结局
- Beck Depression Inventory(90 days)
- Wolf Motor Score(90 days)
- Functional Independence Measure (FIM)(90 days)
- Rivermead Extended Activities of Daily Living (EADL) scale(90 days)
- Medical Outcomes 36 Item(90 days)
研究者
Hana Choe
Assistant Director NeuroIntervention and Neurocritical Care
Abington Memorial Hospital