The Effects of Concussion on Gait and Posture in Individuals With Peripheral Vision Loss

NCT05948501 | Withdrawn

• 1 other identifier: 202303HRD
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Changes in gait and balance often occur in individuals who have suffered a concussion. In addition, a subset of concussed individuals also experience peripheral vision loss. To date, changes in gait and balance have not been examined in individuals who have suffered a concussion and also experience peripheral vision loss.

Conditions

Concussion; Eye

Keywords

Concussion; Postural Control; Peripheral Vision Loss

Outcome Measures

Primary Outcomes (2)

• Balance Test

  Static postural control test on a force plate (AMTI OR-6; Watertown, MA, USA).

  This assessment will be collected upon enrollment in the study consisting of 1 day of testing. Outcome will be averaged across 3 trials.

• Treadmill Walking Test

  Participants will walk on an instrumented treadmill (Treadmetrix SDI; Park City, UT, USA) wearing their own comfortable shoes while their body segment motions will be recorded using an 8-camera markerless motion capture system (Theia Markerless, Inc., Kingston, ON, Canada) configured in an array around the perimeter of the treadmill. The treadmill walking test will utilize the Buffalo Concussion Treadmill Test (BCTT) protocol.

  This assessment will be collected upon enrollment in the study consisting of 1 day of testing

Study Arms (3)

mTBI w/ Visual Impairment

Individuals 18 years or older, current patient of Gaylord Hospital Outpatient Services, within the last 6 months have been diagnosed with a mTBI/concussion with visual field loss of greater than or equal to 20% as determined by a perimetry screening

mTBI w/o Visual Impairment

Individuals 18 years or older, current patient of Gaylord Hospital Outpatient Services, within the last 6 months have been diagnosed with a mTBI/concussion currently presenting with no symptoms consistent with peripheral vision loss.

Healthy Control

Community dwelling adults aged 18 years or older with no diagnosis of mTBI/concussion within the last 6 months. Population will be matched to the concussion population within the age, gender, and height range of the concussion population.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include 3 populations of interest, a healthy control population, a population of individuals diagnosed with mTBI without visual impairment, and a population of individuals diagnosed with mTBI and subsequent visual impairment.

You may qualify if:

• Be 18 years of age or older.
• Be able to understand the study materials and provide informed consent.
• Be a current patient of Gaylord Hospital Outpatient Services.
• Within the last 6 months, have been diagnosed with a mild traumatic brain injury (mTBI)/concussion with visual field loss.
• Currently suffering symptoms consistent with peripheral vision loss.
• Have at least 20% vision loss as determined by a perimetry screening.
• Individuals with a history of one or more prior concussions that preceded the most recent mTBI may be included as long as the symptoms of the last concussion/mTBI had resolved prior to the most recent episode.
• Have completed 3 or fewer rehabilitation sessions prior to biomechanics testing.
• Ability to tolerate using the equipment required to complete the assessments for this study
• Be 18 years of age or older.
• Be able to understand the study materials and provide informed consent.
• Be a current patient of Gaylord Hospital Outpatient Services
• Within the last 6 months, have been diagnosed with a mild traumatic brain injury (mTBI)/concussion without visual field loss
• Currently presenting with no symptoms consistent with peripheral vision loss.
• Have a perimetry no more than XX% vision loss as determined by perimetry screening.

You may not qualify if:

• Moderate to severe TBI as diagnosed by imaging and physician diagnosis
• Participants who answer "YES" to any of the questions on the 2022 Physical Activities Readiness Questionnaire for Everyone (PAR-Q+)
• Current lower extremity injury
• Prior medical history or diagnosis that affects gait and/or balance
• Prior history of peripheral vision loss unrelated to current injury and diagnosis
• Peripheral neuropathy
• Pre-existing visual impairment not corrected by corrective lenses (glasses or contacts)
• Vestibular dysfunction (i.e. positional vertigo) that is unable to be cleared in 1 treatment session
• Cervicogenic range of motion limitations
• Any medical condition/medication that would interfere with subject safety or data collection in the opinion of the PI
• Member of a vulnerable or protected population, including people who are incarcerated, those under the age of 18, and those who are or might be pregnant.

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead
• SOUTHERN CONNECTICUT STATE UNIVERSITY FOUNDATION INC: collaborator

Study Sites (2)

Southern Connecticut State University

New Haven, Connecticut, 06515, United States

Location

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

MeSH Terms

Conditions

Brain Concussion

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

Study Officials

• Gregory Robert

  Southern Connecticut University Foundation Inc

  PRINCIPAL INVESTIGATOR

• Henry Hrdlicka, PhD

  Gaylord Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 17, 2023
• Study Start: May 1, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)