Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion

NCT02317107 | Completed

• 1 other identifier: IRB-P00016317
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations. The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.

Conditions

Brain Concussion

Keywords

Gait; Mild Traumatic Brain Injury; Post-Concussion Syndrome; Recovery of Function; Locomotion; Motor Activity

Outcome Measures

Primary Outcomes (1)

• Dynamic Balance Control

  For balance control measures, the primary data will come from accelerometers placed on specific anatomical landmarks to assess whole body movement. Peak accelerations and velocities of an estimated center-of-mass during gait under single-task and dual-task conditions will identify how divided attention tasks affect whole body balance control.

  1 year

Secondary Outcomes (3)

• Temporal/Distance Gait Measurements

  1 year

• Vestibular-Ocular Motor Screen

  1 year

• Weekly physical and cognitive activity scores

  1 year

Study Arms (2)

Concussion

Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they receive a diagnosis of concussion, defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. If they agree to participate, they will be placed in the concussion group and assessed at each visit to the clinic. No intervention will be administered.

Control

Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they come to the clinic for an injury unrelated to brain function or a lower extremity function (which may affect normal gait patterns). If they agree to participate, they will be placed in the control group and assessed at each visit to the clinic. No intervention will be administered.

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will come from Boston Children's Hospital and The Micheli Center for Sports Injury Prevention. Concussion will be defined consistent with the latest best-practice consensus statement on concussion in sport as a brain injury defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. Informed consent will be obtained after study explanation and sufficient time to answer all study-related questions at each respective location.

You may qualify if:

• Age between 12 and 40 years
• No history of concussion in the past year, and no lifetime history of more than 3 concussions
• Diagnosed with concussion within the past 21 days (concussion group only)

You may not qualify if:

• Lower extremity deficiency or injury, which may affect normal balance or gait
• History of permanent memory loss
• Diagnosis of Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), learning disability, Down syndrome, or developmental delay

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• Howell DR, O'Brien MJ, Raghuram A, Shah AS, Meehan WP 3rd. Near Point of Convergence and Gait Deficits in Adolescents After Sport-Related Concussion. Clin J Sport Med. 2018 May;28(3):262-267. doi: 10.1097/JSM.0000000000000439.

  PMID: 28742610 BACKGROUND

• Howell DR, Stracciolini A, Geminiani E, Meehan WP 3rd. Dual-task gait differences in female and male adolescents following sport-related concussion. Gait Posture. 2017 May;54:284-289. doi: 10.1016/j.gaitpost.2017.03.034. Epub 2017 Apr 1.

  PMID: 28384609 BACKGROUND

• Howell DR, Beasley M, Vopat L, Meehan WP 3rd. The Effect of Prior Concussion History on Dual-Task Gait following a Concussion. J Neurotrauma. 2017 Feb 15;34(4):838-844. doi: 10.1089/neu.2016.4609. Epub 2016 Sep 14.

  PMID: 27541061 BACKGROUND

• Howell DR, Brilliant A, Berkstresser B, Wang F, Fraser J, Meehan WP 3rd. The Association between Dual-Task Gait after Concussion and Prolonged Symptom Duration. J Neurotrauma. 2017 Dec 1;34(23):3288-3294. doi: 10.1089/neu.2017.5191. Epub 2017 Oct 16.

  PMID: 28895490 BACKGROUND

• Berkner J, Meehan WP 3rd, Master CL, Howell DR. Gait and Quiet-Stance Performance Among Adolescents After Concussion-Symptom Resolution. J Athl Train. 2017 Dec;52(12):1089-1095. doi: 10.4085/1062-6050-52.11.23. Epub 2017 Nov 20.

  PMID: 29154694 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Study Officials

• William P Meehan III, MD

  Boston Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 15, 2014
• Study Start: June 30, 2015
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)