Clinical trial NCT03355339: The Effect of Binasal Occlusion on Balance Following a Concussion
Official title: The Effect of Binasal Occlusion on Balance Following a Concussion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion Post Syndrome
Keywords: Balance
Dual-task
King-Devick Test
Saccades
Binasal Occlusion
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postural sway
timeFrame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Secondary outcomes:
measure: Time to completion of the King-Devick Test (KDT)
timeFrame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
measure: Saccadic eye movement
timeFrame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
measure: Post-concussion symptom score (PCSS)
timeFrame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
measure: Neck Disability Index (NDI)
timeFrame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
measure: Dizziness Handicap Inventory (DHI)
timeFrame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Other outcomes:
Locations:
Study officials:
affiliation: University of Ottawa
name: Heidi Sveistrup, PhD
role: PRINCIPAL_INVESTIGATOR
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