Use of the Concussion Pen in Evaluating Ocular-motor Function in the Concussed and Non-concussed Populations Ages 11 to 18 Years Old.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Concussion Pen versus Current Clinical Evaluation
研究概览
简要总结
To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized. This randomization will help to control for evaluation fatigue on the part of study participants.
详细描述
This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
This will be a multi-disciplinary team with members of Physical Therapy (PT)/ Occupational Therapy (OT), Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), and Doctor of Philosophy(PhD)s who specialize in concussion assessment. This study will include a population of concussed patients as well as non-concussed patients (controls) who will be seen in CM clinics per standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for both control and study cohorts, unless stated otherwise below
- •Patients cognitively 11 to 18 years of age.
- •Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population.
- •Patients with a history of concussion at any previous point in time (no time limits to this date).
- •Patients with no history of concussion and being seen at CM PT/OT for other diagnoses for control population.
- •Patients able to give verbal assent or consent (dependent on patient cognitive age), and Legally Authorized Representatives (LAR)s able to give verbal parental permission.
- •English-speaking families.
排除标准
- •Patients not within the inclusion criteria as outlined above.
- •Patients with congenital vestibular dysfunction will not be included.
- •Patients diagnosed with dyslexia or Attention Deficit Hyperactive Disorder (ADHD) will not be included.
- •Non-English-speaking families.
- •Wards of the State will not be approached for this study.
- •Patients with a previous diagnosis of strabismus or convergence insufficiency will be excluded.
结局指标
主要结局
Concussion Pen versus Current Clinical Evaluation
时间窗: 1 year
Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.
次要结局
未报告次要终点
研究者
Andrea Thorne
Principal Investigator, PT
Children's Mercy Hospital Kansas City