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Completed

NCT Number: NCT02317107

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

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.

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Key information

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

To address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the Boston Children's Hospital Sports Concussion Clinic. If patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. Participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity.

During the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. As a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Dynamic Balance Control

    Time frame: 1 year

    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.

Secondary outcomes

  1. Temporal/Distance Gait Measurements

    Time frame: 1 year

    Stride velocity, stride length, gait cycle time, turning duration/velocity, and anticipatory postural adjustments will help to quantify gait stability in different conditions

  2. Vestibular-Ocular Motor Screen

    Time frame: 1 year

    The severity of symptom provocation in each condition of the vestibular-ocular motor test

  3. Weekly physical and cognitive activity scores

    Time frame: 1 year

    Scores rated by the patient will be calculated across their duration of participation in the study and used to associate the amount of activity participated in with the duration of time to recovery

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

A Longitudinal Examination of Dynamic Balance Control, Vestibular/Ocular Motor Function, and Activity Participation Following Concussion

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 15, 2014
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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