Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI

NCT02748109 | Completed

• 2 other identifiers: 15010CDMRP-MR141257
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Our central hypothesis is that chronic balance deficits after mild traumatic brain injury (mTBI) result from impairments in central sensorimotor integration (CSMI) that may be helped by rehabilitation. There are two objectives of this proposal; the first objective is to characterize balance deficits in people with mTBI. The second objective is to use a novel auditory bio-feedback (ABF) device to improve measures central sensorimotor integration and balance control.

Conditions

Brain Injury

Keywords

Physical Therapy; Balance Disorder; Concussion; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention.

  An APDM movement monitor will be worn around the waist to gather information on local activity during the day.

  before and after 6 weeks of intervention

Secondary Outcomes (16)

• Change in Sensory Orientation Test (SOT) Composite Score

  Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes

• Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores

  Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes

• Change in dynamic gait coordination

  Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes

• Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire

  Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes

• Automated Neuropsychological Assessment Metrics (ANAM)

  baseline

Study Arms (2)

Vestibular Rehabilitation + audio biofeedback

EXPERIMENTAL

Vestibular rehabilitation paired with audio biofeedback

Behavioral: Vestibular Rehabilitation + audio biofeedback

Vestibular Rehabilitation

ACTIVE COMPARATOR

Vestibular rehabilitation

Behavioral: Vestibular Rehabilitation

Interventions

Vestibular Rehabilitation + audio biofeedback BEHAVIORAL

Vestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks.

Vestibular Rehabilitation + audio biofeedback

Vestibular Rehabilitation BEHAVIORAL

Standard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks.

Vestibular Rehabilitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• have a diagnosis of mTBI based upon Veterans Health Administration (VHA)/Department of Defense (DoD) criteria with persisting symptoms \>3 months post injury
• have minimal cognitive impairment; a score between 0 and 8 on the Short Blessed test for cognitive function
• may have or not had a loss of consciousness (LOC) with their initial injury
• OR-
• have no recent history of mTBI or brain injury and related complaints

You may not qualify if:

• have had or currently have any other injury, medical, substance or neurological illness that could potentially explain balance deficits (e.g., Central Nervous System disease, stroke, moderate TBI, lower extremity amputation)
• meet criteria for moderate to severe substance use disorder within the past month, as defined by Diagnostic and Statistical Manual (DSM-V)
• display behavior that would significantly interfere with validity of data collection or safety during study
• be in significant pain during the evaluation (5/10 by patient subjective report)
• be a pregnant female (balance considerations)
• have past history of peripheral vestibular pathology or ocular motor deficits
• have significant hearing loss that would interfere with the use of an auditory biofeedback device; hearing loss no worse than 30 decibel (dB) HL (PTA 0.5-3 kHz), in better ear, with the difference in ears being less than 15 dB PTA
• be unable to abstain for 24 hours in advance of testing in the use medications that might impair their balance (meclizine, scopolamine, benzodiazepines such as Valium, sedatives such as Ambien, narcotic pain medications, and antihistamines)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Portland VA Medical Center: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (9)

• Fino PC, Raffegeau TE, Parrington L, Peterka RJ, King LA. Head stabilization during standing in people with persisting symptoms after mild traumatic brain injury. J Biomech. 2020 Nov 9;112:110045. doi: 10.1016/j.jbiomech.2020.110045. Epub 2020 Sep 17.

  PMID: 33011672 BACKGROUND

• Stuart S, Parrington L, Morris R, Martini DN, Fino PC, King LA. Gait measurement in chronic mild traumatic brain injury: A model approach. Hum Mov Sci. 2020 Feb;69:102557. doi: 10.1016/j.humov.2019.102557. Epub 2019 Nov 26.

  PMID: 31783306 BACKGROUND

• Martini DN, Parrington L, Stuart S, Fino PC, King LA. Gait Performance in People with Symptomatic, Chronic Mild Traumatic Brain Injury. J Neurotrauma. 2021 Jan 15;38(2):218-224. doi: 10.1089/neu.2020.6986. Epub 2020 Aug 10.

  PMID: 32495691 BACKGROUND

• Stuart S, Parrington L, Martini DN, Kreter N, Chesnutt JC, Fino PC, King LA. Analysis of Free-Living Mobility in People with Mild Traumatic Brain Injury and Healthy Controls: Quality over Quantity. J Neurotrauma. 2020 Jan 1;37(1):139-145. doi: 10.1089/neu.2019.6450. Epub 2019 Aug 26.

  PMID: 31354032 BACKGROUND

• Peterka RJ, Murchison CF, Parrington L, Fino PC, King LA. Implementation of a Central Sensorimotor Integration Test for Characterization of Human Balance Control During Stance. Front Neurol. 2018 Dec 13;9:1045. doi: 10.3389/fneur.2018.01045. eCollection 2018.

  PMID: 30619027 BACKGROUND

• Fino PC, Wilhelm J, Parrington L, Stuart S, Chesnutt JC, King LA. Inertial Sensors Reveal Subtle Motor Deficits When Walking With Horizontal Head Turns After Concussion. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):E74-E81. doi: 10.1097/HTR.0000000000000418.

  PMID: 30045224 BACKGROUND

• Fino PC, Parrington L, Walls M, Sippel E, Hullar TE, Chesnutt JC, King LA. Abnormal Turning and Its Association with Self-Reported Symptoms in Chronic Mild Traumatic Brain Injury. J Neurotrauma. 2018 May 15;35(10):1167-1177. doi: 10.1089/neu.2017.5231. Epub 2018 Mar 23.

  PMID: 29078732 BACKGROUND

• Fino PC, Peterka RJ, Hullar TE, Murchison C, Horak FB, Chesnutt JC, King LA. Assessment and rehabilitation of central sensory impairments for balance in mTBI using auditory biofeedback: a randomized clinical trial. BMC Neurol. 2017 Feb 23;17(1):41. doi: 10.1186/s12883-017-0812-7.

  PMID: 28231824 BACKGROUND

• Theodoroff SM, Papesh M, Duffield T, Novak M, Gallun F, King L, Chesnutt J, Rockwood R, Palandri M, Hullar T. Concussion Management Guidelines Neglect Auditory Symptoms. Clin J Sport Med. 2022 Mar 1;32(2):82-85. doi: 10.1097/JSM.0000000000000874.

  PMID: 32941367 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurie King, Ph.D., P.T.

  Associate Professor of Neurology, OHSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 22, 2016
• Study Start: May 11, 2016
• Primary Completion: April 11, 2019
• Study Completion: June 24, 2019
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)