The Effect of Binasal Occlusion on Balance Following a Concussion

NCT03355339 | Unknown

• 1 other identifier: H06-17-20
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Concussion Post Syndrome

Keywords

Balance; Dual-task; King-Devick Test; Saccades; Binasal Occlusion

Outcome Measures

Primary Outcomes (1)

• 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.

  After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.

Secondary Outcomes (5)

• 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.

• Saccadic eye movement

  After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.

• 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.

• Neck Disability Index (NDI)

  After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.

• Dizziness Handicap Inventory (DHI)

  After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.

Study Arms (2)

Binasal occlusion

EXPERIMENTAL

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

Device: Binasal occlusion

No binasal occlusion

ACTIVE COMPARATOR

Participants will be fitted with non-occluded glasses.

Device: No binasal occlusion

Interventions

Binasal occlusion DEVICE

Binasal occlusion glasses

Binasal occlusion

No binasal occlusion DEVICE

Non-occluded glasses

No binasal occlusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Ottawa: lead

Related Publications (31)

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Related Links

• Tobii Pro

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Heidi Sveistrup, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacquie J van Ierssel, PT, MSc

CONTACT

613-562-5800; jminn044@uottawa.ca

Jennifer O'Neil, PT, MSc

CONTACT

613-562-5800; joneil@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 28, 2017
• Study Start: November 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share