The Effect of Binasal Occlusion on Balance Following a Concussion
NCT ID: NCT03355339
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-11-30
2019-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Binasal occlusion
Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens.
Binasal occlusion
Binasal occlusion glasses
No binasal occlusion
Participants will be fitted with non-occluded glasses.
No binasal occlusion
Non-occluded glasses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Binasal occlusion
Binasal occlusion glasses
No binasal occlusion
Non-occluded glasses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Ottawa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jacquie van Ierssel
Principle Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heidi Sveistrup, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Broglio SP, Tomporowski PD, Ferrara MS. Balance performance with a cognitive task: a dual-task testing paradigm. Med Sci Sports Exerc. 2005 Apr;37(4):689-95. doi: 10.1249/01.mss.0000159019.14919.09.
Chang JO, Levy SS, Seay SW, Goble DJ. An alternative to the balance error scoring system: using a low-cost balance board to improve the validity/reliability of sports-related concussion balance testing. Clin J Sport Med. 2014 May;24(3):256-62. doi: 10.1097/JSM.0000000000000016.
Ciuffreda KJ, Yadav NK, Ludlam DP. Effect of binasal occlusion (BNO) on the visual-evoked potential (VEP) in mild traumatic brain injury (mTBI). Brain Inj. 2013;27(1):41-7. doi: 10.3109/02699052.2012.700088. Epub 2012 Aug 17.
Ciuffreda KJ, Yadav NK, Ludlam DP. Binasal Occlusion (BNO), Visual Motion Sensitivity (VMS), and the Visually-Evoked Potential (VEP) in mild Traumatic Brain Injury and Traumatic Brain Injury (mTBI/TBI). Brain Sci. 2017 Aug 9;7(8):98. doi: 10.3390/brainsci7080098.
Degani AM, Santos MM, Leonard CT, Rau TF, Patel SA, Mohapatra S, Danna-Dos-Santos A. The effects of mild traumatic brain injury on postural control. Brain Inj. 2017;31(1):49-56. doi: 10.1080/02699052.2016.1225982. Epub 2016 Dec 12.
Galetta KM, Liu M, Leong DF, Ventura RE, Galetta SL, Balcer LJ. The King-Devick test of rapid number naming for concussion detection: meta-analysis and systematic review of the literature. Concussion. 2015 Sep 10;1(2):CNC8. doi: 10.2217/cnc.15.8. eCollection 2016 Mar.
Galetta KM, Morganroth J, Moehringer N, Mueller B, Hasanaj L, Webb N, Civitano C, Cardone DA, Silverio A, Galetta SL, Balcer LJ. Adding Vision to Concussion Testing: A Prospective Study of Sideline Testing in Youth and Collegiate Athletes. J Neuroophthalmol. 2015 Sep;35(3):235-41. doi: 10.1097/WNO.0000000000000226.
Gallop S. A variation on the use of binasal occlusion glasses - a case study. Journal of Behavioural Optometry 9(2): 31-35, 1998.
Gallop S. Viewpoint 4 Binasal Occlusion - Immediate , Sustainable Symptomatic Relief. Optometry & Visual Performance 9(2):31-35, 2014.
Goble DJ, Manyak KA, Abdenour TE, Rauh MJ, Baweja HS. AN INITIAL EVALUATION OF THE BTRACKS BALANCE PLATE AND SPORTS BALANCE SOFTWARE FOR CONCUSSION DIAGNOSIS. Int J Sports Phys Ther. 2016 Apr;11(2):149-55.
Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
Hunt AW, Mah K, Reed N, Engel L, Keightley M. Oculomotor-Based Vision Assessment in Mild Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2016 Jul-Aug;31(4):252-61. doi: 10.1097/HTR.0000000000000174.
Kamins J, Bigler E, Covassin T, Henry L, Kemp S, Leddy JJ, Mayer A, McCrea M, Prins M, Schneider KJ, Valovich McLeod TC, Zemek R, Giza CC. What is the physiological time to recovery after concussion? A systematic review. Br J Sports Med. 2017 Jun;51(12):935-940. doi: 10.1136/bjsports-2016-097464. Epub 2017 Apr 28.
Kleffelgaard I, Roe C, Soberg HL, Bergland A. Associations among self-reported balance problems, post-concussion symptoms and performance-based tests: a longitudinal follow-up study. Disabil Rehabil. 2012;34(9):788-94. doi: 10.3109/09638288.2011.619624. Epub 2011 Dec 9.
Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
Levac D, DeMatteo C, Hanna S, Wishart L. Intra-individual variability in recovery from paediatric acquired brain injury: relationship to outcomes at 1 year. Dev Neurorehabil. 2008 Jul;11(3):195-203. doi: 10.1080/17518420802055177.
Lovell MR, Iverson GL, Collins MW, Podell K, Johnston KM, Pardini D, Pardini J, Norwig J, Maroon JC. Measurement of symptoms following sports-related concussion: reliability and normative data for the post-concussion scale. Appl Neuropsychol. 2006;13(3):166-74. doi: 10.1207/s15324826an1303_4.
MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930.
Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14.
Master CL, Scheiman M, Gallaway M, Goodman A, Robinson RL, Master SR, Grady MF. Vision Diagnoses Are Common After Concussion in Adolescents. Clin Pediatr (Phila). 2016 Mar;55(3):260-7. doi: 10.1177/0009922815594367. Epub 2015 Jul 7.
McCrea MA, Nelson LD, Guskiewicz K. Diagnosis and Management of Acute Concussion. Phys Med Rehabil Clin N Am. 2017 May;28(2):271-286. doi: 10.1016/j.pmr.2016.12.005. Epub 2017 Mar 1.
McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available.
O'Connor SM, Baweja HS, Goble DJ. Validating the BTrackS Balance Plate as a low cost alternative for the measurement of sway-induced center of pressure. J Biomech. 2016 Dec 8;49(16):4142-4145. doi: 10.1016/j.jbiomech.2016.10.020. Epub 2016 Oct 20.
Patricios J, Fuller GW, Ellenbogen R, Herring S, Kutcher JS, Loosemore M, Makdissi M, McCrea M, Putukian M, Schneider KJ. What are the critical elements of sideline screening that can be used to establish the diagnosis of concussion? A systematic review. Br J Sports Med. 2017 Jun;51(11):888-894. doi: 10.1136/bjsports-2016-097441. Epub 2017 Mar 7.
Proctor A. Traumatic brain injury and binasal occlusion. Optometry and Vision Development, 40(1): 45-50, 2009.
Rizzo JR, Hudson TE, Dai W, Birkemeier J, Pasculli RM, Selesnick I, Balcer LJ, Galetta SL, Rucker JC. Rapid number naming in chronic concussion: eye movements in the King-Devick test. Ann Clin Transl Neurol. 2016 Sep 1;3(10):801-811. doi: 10.1002/acn3.345. eCollection 2016 Oct.
Rochefort C, Walters-Stewart C, Aglipay M, Barrowman N, Zemek R, Sveistrup H. Balance Markers in Adolescents at 1 Month Postconcussion. Orthop J Sports Med. 2017 Mar 17;5(3):2325967117695507. doi: 10.1177/2325967117695507. eCollection 2017 Mar.
Scoppa F, Capra R, Gallamini M, Shiffer R. Clinical stabilometry standardization: basic definitions--acquisition interval--sampling frequency. Gait Posture. 2013 Feb;37(2):290-2. doi: 10.1016/j.gaitpost.2012.07.009. Epub 2012 Aug 11.
Subotic A, Ting WK, Cusimano MD. Characteristics of the King-Devick test in the assessment of concussed patients in the subacute and later stages after injury. PLoS One. 2017 Aug 31;12(8):e0183092. doi: 10.1371/journal.pone.0183092. eCollection 2017.
Yadav NK, Thiagarajan P, Ciuffreda KJ. Effect of oculomotor vision rehabilitation on the visual-evoked potential and visual attention in mild traumatic brain injury. Brain Inj. 2014;28(7):922-9. doi: 10.3109/02699052.2014.887227. Epub 2014 Feb 24.
Zemek RL, Farion KJ, Sampson M, McGahern C. Prognosticators of persistent symptoms following pediatric concussion: a systematic review. JAMA Pediatr. 2013 Mar 1;167(3):259-65. doi: 10.1001/2013.jamapediatrics.216.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Tobii Pro
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H06-17-20
Identifier Type: -
Identifier Source: org_study_id