The Effect of Binasal Occlusion on Balance Following a Concussion

Sponsor

University of Ottawa (Other)

Overall Status

Unknown status

CT.gov ID

NCT03355339

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Concussion Post Syndrome	Device: Binasal occlusion Device: No binasal occlusion	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Binasal Occlusion on Balance Following a Concussion

Anticipated Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Binasal occlusion Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens.	Device: Binasal occlusion Binasal occlusion glasses
Active Comparator: No binasal occlusion Participants will be fitted with non-occluded glasses.	Device: No binasal occlusion Non-occluded glasses

Arm

Intervention/Treatment

Experimental: Binasal occlusion

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

Device: Binasal occlusion

Binasal occlusion glasses

Active Comparator: No binasal occlusion

Participants will be fitted with non-occluded glasses.

Device: No binasal occlusion

Non-occluded glasses

Outcome Measures

Primary Outcome Measures

Postural sway [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.

Secondary Outcome Measures

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.]
The KDT is a vision-based test of rapid number naming speed that acts as a proxy measure for saccadic eye movement. The KDT consists of a demonstration card, plus a series of 3 increasingly more difficult test cards of variably spaced single digit numbers. Following completion of the demonstration card, participants are asked to read each test card from left to right, top to bottom, as quickly as possible without errors. A summary score of the test is recorded as the total time to complete all 3 test cards, measured in seconds. Time to completion for the KDT will be recorded. Any increase in time compared with a control condition, or any uncorrected errors are considered a significant change.
Saccadic eye movement [After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.]
Saccadic eye movement will be assessed with a Tobii™ Pro wearable eye tracker. Tobii™ Pro wearable eye tracker uses infrared video-oculography to analyze patterns of eye movement in terms of fixations and saccades. Longer, more complicated visual tasks, such as rapid number naming, require longer processing times. The number of saccades completed during each balance condition will be recorded by the Tobii™ Pro.
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.]
The PCSS is a standardized and easily administered 22-item self-report symptom scale that measures the severity of each symptom experienced that day. Symptoms are reported on a 7-point Likert scale, with 0 and 6 representing anchoring points from the absence of symptoms to the presence of severe symptoms. Results are conveyed as the total symptom score and range from 0-132, with a higher score associated with a higher level of symptoms. Total scores demonstrate high internal consistency in a concussion population (α=0.93), with a 6.8 point change (80% CI) associated with a clinical change in symptoms.
Neck Disability Index (NDI) [After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.]
The NDI is the most commonly used self-report outcome measure for neck pain. The index is a simple and quickly administered 10-item questionnaire measured on a 6-point Likert scale from 0=no disability to 5 = full disability. Scores range from 0-50, with 50 representing the highest level of disability. Clinically important difference have been reported with a 5-7 point change in score depending on whether the pain was of musculoskeletal or neural origin.
Dizziness Handicap Inventory (DHI) [After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.]
The DHI is a self-report measure of disability associated with dizziness. Internal consistency is high for total scores (α = 0.89). The presence of dizziness-related disability is scored as no (0), sometimes (2), or yes (4). Scores range from 0-100, with a higher score reflecting a greater disability associated with dizziness. Cut-off scores exist for mild (16-34), moderate (36-52), and severe (54+) disability, with an 18-point change in score considered clinically meaningful.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.