Clinical Evaluation of a Novel Balance, Vestibular and Oculomotor Assessment Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- User Experience assessed by the iDETECT User Experience Survey
研究概览
简要总结
The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain injury) system is a novel portable, open access platform that enables immediate and rapid assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT function testing battery with currently used balance and inner ear assessment methods during initial concussion clinic referral. Two groups of participants will be enrolled; a concussion related dizziness cohort and control subjects. The investigators will enroll the concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent dizziness and imbalance symptoms following possible concussion. Healthy control participants will be recruited from the local community. iDETECT's ability to identify post concussion balance/vestibular disturbances will be compared to an expert concussion assessment. Both cohorts will participate in the iDETECT assessment and the clinical assessment.
详细描述
The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain injury) system is a novel portable, open access platform that enables immediate and rapid assessment of multimodal neurologic function. This study seeks to evaluate and validate the iDETECT balance, vestibular, and oculomotor testing battery with clinician performed balance and vestibular assessment methods. Two groups of participants will be enrolled; concussion related dizziness cohort and control subjects (no concussion or dizzy symptoms). The investigators will enroll the concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent dizziness and imbalance symptoms following possible concussion. Healthy control participants with normal vestibular function and no history of concussion will be recruited from the local community. All participants will be tested with both the iDETECT balance and vestibular assessment battery and the current clinical reference standards for imbalance and vestibular dysfunction performed by a clinician. Performance on the iDETECT balance and vestibular assessment battery will be compared between normal controls and the concussion cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of concussion within prior 6 months
- •Complaint or symptoms of dizziness / balance problems
排除标准
- •History of any of the following:Depression, sleep apnea, seizure disorder, migraine headaches, prior brain or spine surgery, peripheral neuropathy, lower extremity orthopedic problems
- •Chronic drug or alcohol use; or drug or alcohol use within the previous 24 hours.
- •Control Cohort
- •Inclusion Criteria:
- •Physically active (at least 60 min of exercise, team-based or recreational, 3 times of week)
- •Exclusion Criteria:
- •Concussion or concussive-like symptoms within prior 6 months
- •Current complaint or symptoms of dizziness/balance problems
- •History of any of the following:
- •Depression, sleep apnea, seizure disorder, claustrophobia, prior central nervous system (CNS) surgery, peripheral neuropathy, developmental delay, learning disabilities lower extremity orthopedic problems that prevent standing or walking
- •Participants also cannot currently be the under care of a doctor these or any related conditions that may cause cognitive impairment.
- •Chronic drug or alcohol use; or drug or alcohol use within the previous 24 hours
结局指标
主要结局
User Experience assessed by the iDETECT User Experience Survey
时间窗: Post iDETECT testing (Up to three minutes)
The iDETECT User Experience Survey will be used to evaluate participant's experiences with iDETECT as is designed to gather information to help investigators improve the design and effectiveness of iDETECT. It is a thirteen point questionnaire in which participants will rate their experience with the iDETECT tool on a scale from "strongly agree" and "strongly disagree".
Simulator Sickness assessed by the Simulator Sickness Questionnaire (SSQ)
时间窗: Post iDETECT testing (Up to three minutes)
The Simulator Sickness Questionnaire (SSQ) is a 16-item simulator sickness questionnaire. Participants mark the extent to which they are experiencing various after effects on a scale from 0 to 3 with higher numbers indicating greater severity.
Presence of Post Concussive Symptoms assessed by the Post Concussion Symptoms Scale (PCSS)
时间窗: Post iDETECT testing (Up to three minutes)
The Post Concussion Symptoms Scale (PCSS) is a self-report measure with 22 post concussive symptom items graded on a scale from 0 (no symptoms) to 6 (severe symptoms).
次要结局
- Imbalance assessed by the Balance Error Scoring System (BESS) Score(Visit 0 (Up to ten minutes))
- Postural Stability assessed by Quantitative Balance Testing (BioSway) Score(Visit 0 (Up to five minutes))
- Visual Acuity assessed by the Dynamic Visual Acuity (DVA) Test(Visit 0 (Up to five minutes))
- Vestibular Function assessed by Vestibular/Ocular-Motor Screening (VOMS)(Visit 0 (Up to ten minutes))
- Dynamic Gait Ability assessed by Dynamic Gait Index (DGI) Score(Visit 0 (Up to ten minutes))
- High Level Balance assessed by the High-level Mobility Assessment Tool (HiMAT)(Visit 0 (Up to ten minutes))
- Mobility assessed by the High-level Mobility Assessment Tool (HiMAT)(Visit 0 (Up to ten minutes))
- Confidence in Balance assessed by the Activities-specific Balance Confidence (ABC) Scale(Visit 0 (Up to ten minutes))
- Dizziness assessed by the Dizziness Handicap Inventory (DHI)(Visit 0 (Up to ten minutes))
- Visual Vertigo Symptoms assessed by the Visual Vertigo Analog Scale (VVAS)(Visit 0 (Up to ten minutes))
研究者
David Wright
Associate Professor
Emory University