Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Impact Neurological Scores
研究概览
简要总结
The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).
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
- Male
- 接受健康志愿者
- 是
入选标准
- •18 Years or older
- •Male Unarmed Combat Athlete
- •30-day suspension (head injury without technical knockout or incapacitation)
- •60-day suspension (head injury with technical knockout or incapacitation)
- •90-day suspension (head injury with loss of consciousness)
排除标准
- •Prisoner status
- •Suspension group injury severity would not include moderate to severe GCS <13
- •These suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. This group will be divided into randomized groups, patients who will be treated with HBOT and patients who will receive the standard of care, which is rest.
研究组 & 干预措施
HBOT Treatment Group
干预措施: Hyberbaric Oxygen Therapy (Device)
Conventional Rest Control Group
结局指标
主要结局
Impact Neurological Scores
时间窗: 13 Weeks
The Impact scores are a percentile 1% to 100%. Any score under 50% is considered a need for neurological or primary care consultation for a concussion
次要结局
未报告次要终点
研究者
Michael Harl
Physician - Plastic Surgery
Marshfield Clinic Research Foundation
