The Effect of Binasal Occlusion on Balance Following a Concussion
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Postural sway
研究概览
简要总结
This study evaluates the effect of binasal occlusion (BNO) glasses on balance and eye movement in adults with dizziness after a concussion. Participants will stand on a force plate while rapidly reading a series of numbers both with and without the BNO glasses. It is thought that the BNO glasses will improve both balance and the time to read the numbers.
详细描述
While most individuals will recover within the first month after concussion, a significant number will continue to experience dizziness, balance problems, cognitive deficits, and vision problems. Single-task measures of static balance may not be sensitive enough, however, to capture mild postural changes still associated with incomplete recovery. Increasingly there is an interest in dual-task paradigms of balance assessment as a more accurate representation of functional postural control associated with activities of daily living and sport participation. Binasal occlusion (BNO) has been proposed as a means of providing visual stabilization to improve postural control in individuals with vision-related balance problems following a concussion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forty adults with persistent symptoms one month or more following a concussion will be recruited for the study. Individuals will be considered eligible if they have been diagnosed with a concussion as defined in the 2016 Berlin consensus statement (McCrory et al., 2017) as a traumatic brain injury induced by biomechanics forces, which was caused by either a direct or indirect blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head, which may or may not have involved loss of consciousness, and included one or more of the following clinical domains:
- •Symptoms (e.g. headache, nausea, fatigue, feeling like in a fog, difficulty concentrating or remembering, and/or emotional lability)
- •Physical signs (e.g. loss of consciousness, amnesia, neurological deficit);
- •Balance impairment (e.g. gait unsteadiness)
- •Behavioural changes (e.g. irritability)
- •Cognitive impairment (e.g. slowed reaction times)
- •Sleep/wake disturbance (e.g. somnolence, drowsiness) Participants must also meet the following inclusion criteria: (1) aged 18-65 years; (2) sustained the concussion 4 or more weeks ago; (3) report persistent dizziness or balance problems not accounted for by a pre-existing musculoskeletal, neurological, or vestibular condition; (4) have normal vision or visual impairments that can be corrected with contact lenses; (5) are proficient in English or French; (6) are able to provide informed consent.
排除标准
- •Do not meet criteria stipulated in the inclusion criteria
研究组 & 干预措施
Binasal occlusion
Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens.
干预措施: Binasal occlusion (Device)
No binasal occlusion
Participants will be fitted with non-occluded glasses.
干预措施: No binasal occlusion (Device)
结局指标
主要结局
Postural sway
时间窗: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
The primary outcome of interest is the mean medial/lateral and anterior/posterior velocity of centre of pressure, in addition to the 95% ellipse during different conditions of static balance. The minimal clinical difference considered to demonstrate a change in postural sway is 5cm based on previous validation of the Balance TrackS force plate in a concussed population.
次要结局
- Dizziness Handicap Inventory (DHI)(After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.)
- Post-concussion symptom score (PCSS)(After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.)
- Saccadic eye movement(After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.)
- Time to completion of the King-Devick Test (KDT)(After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.)
- Neck Disability Index (NDI)(After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.)
研究者
Jacquie van Ierssel
Principle Investigator
University of Ottawa