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Search / Trial NCT05948501

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

Launched by GAYLORD HOSPITAL, INC · Jul 13, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Concussion Postural Control Peripheral Vision Loss

ClinConnect Summary

This clinical trial is exploring how a concussion affects walking and balance, particularly in people who also have trouble with their side (peripheral) vision. Researchers want to understand these effects better, especially since many individuals who have had concussions also experience some level of vision loss. Currently, the trial is not yet recruiting participants, but it aims to include adults aged 18 and older who have either suffered a mild traumatic brain injury (mTBI) with or without visual impairment or who are healthy controls without any history of concussions.

To participate, individuals must meet certain criteria, such as being a patient at Gaylord Hospital Outpatient Services and having experienced a concussion within the last six months. Those with prior concussions may also be included if their symptoms have resolved. Participants will undergo assessments that require them to use specialized equipment to evaluate their gait and balance. It’s important to note that anyone with certain medical conditions or ongoing injuries will not be eligible for this study. Overall, the trial aims to gather valuable information that could lead to better treatment and support for individuals who have experienced concussions and vision loss.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria; mTBI w/ Visual Impairment:
  • 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
  • Inclusion Criteria; mTBI w/o Visual Impairment
  • 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.
  • 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
  • Inclusion Criteria; Healthy Control
  • Be a community dwelling adult 18 years of age or older.
  • Be able to understand the study materials and provide informed consent.
  • Have not experienced or been diagnosed with a concussion in the last 6 months
  • Individuals with a history of one or more prior concussions, with or without vision loss, longer than 6 months prior to study recruitment may be considered as long as the symptoms of the last concussion/mTBI have resolved.
  • Currently presenting with no symptoms consistent with peripheral vision loss.
  • Have a perimetry no more than XX% vision loss as determined by perimetry screening.
  • Ability to tolerate using the equipment required to complete the assessments for this study
  • As this population will be matched to the concussion population, individuals must match fall within the age, gender, and height range of the concussion population
  • Exclusion Criteria:
  • 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.

About Gaylord Hospital, Inc

Gaylord Hospital, Inc. is a leading healthcare institution dedicated to providing specialized rehabilitation services and innovative clinical trials aimed at improving patient outcomes. With a commitment to excellence in patient care and research, Gaylord Hospital leverages its state-of-the-art facilities and multidisciplinary expertise to explore new therapeutic interventions and enhance the quality of life for individuals with complex medical conditions. The organization fosters a collaborative environment that prioritizes safety, ethical standards, and patient-centered approaches in all clinical research initiatives.

Locations

New Haven, Connecticut, United States

Wallingford, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Gregory Robert

Principal Investigator

Southern Connecticut University Foundation Inc

Henry Hrdlicka, PhD

Principal Investigator

Gaylord Specialty Healthcare

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported