Back to resultsThe Effect of Binasal Occlusion on Balance Following a Concussion
Primary Purpose
Concussion Post Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Binasal occlusion
No binasal occlusion
Sponsored by
About this trial
This is an interventional treatment trial for Concussion Post Syndrome focused on measuring Balance, Dual-task, King-Devick Test, Saccades, Binasal Occlusion
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Binasal occlusion
No binasal occlusion
Arm Description
Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens.
Participants will be fitted with non-occluded glasses.
Outcomes
Primary Outcome Measures
Postural sway
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)
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
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)
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)
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)
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.
Full Information
NCT ID
NCT03355339
First Posted
November 9, 2017
Last Updated
October 29, 2018
Sponsor
University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT03355339
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion Post Syndrome
Keywords
Balance, Dual-task, King-Devick Test, Saccades, Binasal Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Binasal occlusion
Arm Type
Experimental
Arm Description
Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens.
Arm Title
No binasal occlusion
Arm Type
Active Comparator
Arm Description
Participants will be fitted with non-occluded glasses.
Intervention Type
Device
Intervention Name(s)
Binasal occlusion
Intervention Description
Binasal occlusion glasses
Intervention Type
Device
Intervention Name(s)
No binasal occlusion
Intervention Description
Non-occluded glasses
Primary Outcome Measure Information:
Title
Postural sway
Description
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.
Time Frame
After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Secondary Outcome Measure Information:
Title
Time to completion of the King-Devick Test (KDT)
Description
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.
Time Frame
After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Title
Saccadic eye movement
Description
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.
Time Frame
After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Title
Post-concussion symptom score (PCSS)
Description
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.
Time Frame
After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Title
Dizziness Handicap Inventory (DHI)
Description
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.
Time Frame
After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquie J van Ierssel, PT, MSc
Phone
613-562-5800
Ext
7099
Email
jminn044@uottawa.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer O'Neil, PT, MSc
Phone
613-562-5800
Ext
7099
Email
joneil@uottawa.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Sveistrup, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Binasal Occlusion on Balance Following a Concussion
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