The Effect of Binasal Occlusion on Balance Following a Concussion

University of Ottawa

Status: Unknown

Conditions: Concussion Post Syndrome

Treatments: Device: Binasal occlusion; Device: No binasal occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03355339

H06-17-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• Do not meet criteria stipulated in the inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Binasal occlusion

Experimental group

Description:

Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens.

Treatment:

Device: Binasal occlusion

No binasal occlusion

Active Comparator group

Description:

Participants will be fitted with non-occluded glasses.

Treatment:

Device: No binasal occlusion