Oculomotor Rehabilitation After Concussion in Adults: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
After concussion, many individuals experience vision-related symptoms such as blurred vision, difficulty reading, and discomfort in visually stimulating environments, which can interfere with return to work, school, and daily activities. Oculomotor rehabilitation (OMR) is used by some clinicians to address these symptoms, but there is limited high-quality evidence to support its use. Prior to conducting a fully powered randomized controlled trial, it is necessary to determine whether such a study is feasible. This study aims to evaluate the feasibility of conducting a randomized trial comparing a six-week OMR program to usual care in adults with concussion. Adults aged 18 to 42 years who sustained a concussion 30 days to 12 months prior and report symptoms suggestive of oculomotor impairment will be recruited from an outpatient concussion clinic at the University Health Network and the community in Toronto, Ontario. Participants will be randomized to either a six-week OMR program consisting of weekly 60-minute clinic visits using head-mounted eye-tracking technology with prescribed home exercises, or usual care consisting of education and symptom management strategies. Feasibility outcomes will include recruitment rate, retention, perceived benefit of the OMR intervention, and safety (adverse events). Outcomes will be assessed at baseline and after six weeks. The findings will inform the design and implementation of a future trial evaluating the effectiveness of oculomotor rehabilitation after concussion.
详细描述
Background Concussion is a common form of mild traumatic brain injury (mTBI) that produces a broad and heterogeneous range of symptoms and functional deficits affecting daily activities including work, school, sport, and social participation. Recovery is highly individualized and influenced by injury characteristics, personal medical history (e.g., anxiety, migraine history), and biological sex and sociocultural gender. Over 50% of individuals from the general population experience symptoms beyond four weeks. In mixed-mechanism populations, mean time to recovery is approximately 6.5 weeks for females and 5.5 weeks for males, suggesting that females may experience a longer symptom course following concussion.
Among the most prevalent clinical profiles of concussion are symptoms attributable to oculomotor dysfunction. Functional deficits in saccades, smooth pursuits, vergence, and pupillary light reflex occur far more frequently than structural injuries, making them a feasible and clinically important rehabilitation target. These deficits can manifest as blurred vision, dizziness, light sensitivity, eye strain, and difficulty tolerating visually busy environments, with downstream impacts on return to work, school, and sport. Without directed rehabilitation, these symptoms often persist.
Oculomotor rehabilitation (OMR) aims to retrain impaired eye movement functions through targeted, restitutive exercise protocols. A systematic review conducted by the study team demonstrated improvements in near point of convergence, reading rate, and visual search and attention following OMR; however, certainty of evidence was rated as low due to methodological limitations, small sample sizes, and variability in protocols. Since that review, additional studies have been published strengthening the evidence base, though existing randomized controlled trials have focused predominantly on adolescents and young adults, limiting generalizability to older adult populations.
Interest in virtual reality (VR)-based OMR delivery has grown substantially. A recent scoping review identified 10 studies using VR for post-concussion vestibular rehabilitation, reporting good tolerability and greater participant enjoyment relative to traditional approaches. To the investigators' knowledge, no published study has systematically examined the feasibility, acceptability, or perceived benefit of delivering OMR via head-mounted VR goggles combined with mobile application-based home exercise programming in adults with persisting oculomotor deficits post-concussion.
Biological sex and sociocultural gender differences in concussion reporting, symptom experience, and recovery have been documented, yet sex and gender have not been adequately explored in the context of OMR. This trial is designed to collect sex-disaggregated data to inform future research in this area.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 to 42 years of age) with a diagnosis of a concussion by a medical doctor between 30 days and 12 months prior
- •Endorsed oculomotor related symptoms indicated by rating "moderate" or "severe" blurred-vision, double vision and/or light sensitivity.
- •Normal stereopsis (depth perception) as measured with the Stereo Fly Test
- •Equal (within one line difference) visual acuity between eyes as measured with the Snellen Eye Chart (Snellen, 1892) (corrected, as applicable)
- •Intact extraocular movements and visual fields
- •Pupils equal, round, and reactive to light and accommodation
- •Healthy fundoscopic findings
- •Ability to read and communicate in English
排除标准
- •Diagnosed eye disease (i.e. glaucoma)
- •Visual acuity less than 20/80 measured using the Snellen Eye Chart
- •Severe neurocognitive deficits expected to interfere with participation
- •Residence more than 100 km from the study site
结局指标
主要结局
Feasibility of Recruitment
时间窗: 12 months
Defined as the ability to recruit at least 32 individuals over a 12 month period.
Perceived Benefit of the Intervention by Participants Allocated to OMR.
时间窗: Measured at final testing (8 weeks post enrollement).
Perceived benefit of OMR in contributing to improvement in symptoms of concussion of at least 85% as measured on a scale of 0-4 (0 no benefit to 4 significant benefit) as reported after participating in 6 weekly sessions of OMR. Measured at final testing for participants in the OMR group.
Completion Rate of at Least 85%
时间窗: At study completion (approximately 8 weeks per participant).
The percentage of participants completing all study requirements including: Baseline data collection, the assigned intervention, and final testing. The assigned intervention as described in the intervention section.
Harms or Adverse Events
时间窗: From enrolment to final testing at 8 weeks post enrolment.
No harms or adverse events (undesirable or unintended medical occurrence experienced by a study participant, regardless of whether it is directly caused by the intervention) reported by any participant from baseline through final testing, including during and immediately after intervention.
次要结局
- Randomization Rate(Over the 12-month recruitment period.)
- Compliance to Allocated Treatment Arm(Over 6 week intervention period, measured at final testing 8 weeks post enrollment.)
- Magnitude of Co-intervention(Throughout the 6-week intervention period.)
- Tolerance to VR-based Assessment and Training(Immediately after each weekly OMR intervention session; (for 6 weeks).)
- Homework Participation(Measured weekly over the 6-week intervention period.)
- Study Experience Rating(Measured once after final testing (8 weeks post enrollment).)
- Technology Reliability(At each participant visit over the entire study period (approximately 16 months).)
- Oculomotor Metrics Capture(From baseline to final testing 8 weeks post enrollment.)
- BIVSS Feasibility as Primary Outcome(Baseline and final testing (8 weeks post-randomization))