CompletedNot Applicable

Oculomotor Rehabilitation After Concussion in Adults: A Feasibility Study

Canada40 participantsStarted 2024-05-06

Plain-language summary

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.

Who can participate

Age range

18 Years – 42 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of Recruitment

Timeframe: 12 months

Perceived Benefit of the Intervention by Participants Allocated to OMR.

Timeframe: Measured at final testing (8 weeks post enrollement).

Completion Rate of at Least 85%

Timeframe: At study completion (approximately 8 weeks per participant).

Harms or Adverse Events

Timeframe: From enrolment to final testing at 8 weeks post enrolment.

Trial details

NCT IDNCT07709936

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-12

View on ClinicalTrials.gov More Concussion trials