Clinical trial NCT02748109: Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
Official title: Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Keywords: Physical Therapy
Balance Disorder
Concussion
Mild Traumatic Brain Injury
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
First posted: 2016-04-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Objectives: This study as two parts: 1) Cross-sectional study (Aim I: Balance Assessment) to identify and characterize maladaptive balance control strategies after mTBI compared to healthy controls and 2) Interventional randomized pilot study (Aim II: Balance Rehabilitation) using a novel ABF rehabilitation technique to ameliorate maladaptive balance control strategies after TBI. Subjects in Aim II will be a subset from Aim I and studies will occur simultaneously.

Plan: The proposed 4-year study has two parts: 1) Cross-sectional study (Aim I: Balance Assessment) to identify and characterize maladaptive balance control strategies after mTBI compared to healthy controls and 2) Interventional randomized pilot study (Aim II: Balance Rehabilitation) using a novel ABF rehabilitation technique to ameliorate maladaptive balance control strategies after TBI. Subjects in Aim II will be a subset from Aim I and studies will occur simultaneously.

Methods: I) Balance Assessment: To characterize balance deficits in people with mTBI who have chronic, non-resolving balance deficits compared to healthy control subjects without a history of mTBI. We hypothesize that a) objective measures of central sensorimotor integration, static and dynamic balance will better distinguish people with mTBI from control subjects than clinical measures, b) a subset of people with mTBI will have abnormal central sensori-motor integration (CSMI) test measures, even without peripheral vestibular or ocular motor deficits c) the relationship between poorer static/dynamic balance performance and mTBI is regulated/mediated by CSMI. We will test 130 subjects between the ages of 18 and 60; 65 with chronic (\> 3 months) mTBI and non-resolving balance deficits and 65 healthy age and gender matched control subjects without a history of mTBI. We will obtain objective measures of static and dynamic balance using wearable inertial sensors and determine how these measures relate to central sensorimotor integration. We will also obtain laboratory measures of peripheral vestibular function and ocular motor function to help classify people and to consider as potential covariates in rehabilitation efficacy.

II) Balance Rehabilitation: To determine the efficacy of a novel, ABF balance rehabilitation program to improve central sensorimotor integration, static and dynamic balance, and functional activity in patients with chronic mTBI. We hypothesize that a) CSMI scores will improve with rehabilitation and ABF will increase the improvement of CSMI scores beyond the standard of care, b) ABF intervention will improve objective summary measures of balance and c) people with central sensorimotor integration impairment will show sustained improvement in CSMI scores and balance after rehabilitation. We will randomize 40 subjects between the ages of 18 and 60; 65 with chronic (\> 3 months) mTBI and non-resolving balance deficits from Aim I who have abnormal CSMI into either the ABF rehabilitation group or the standard of care group. People will be tested before and after a 6-week intervention period and again 6 week later to determine long-term changes. Normal/abnormal vestibular and ocular motor function will be used as covariates to determine if peripheral deficits affect the efficacy of ABF rehabilitation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention.
timeFrame: before and after 6 weeks of intervention
Secondary outcomes:
measure: Change in Sensory Orientation Test (SOT) Composite Score
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
measure: Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
measure: Change in dynamic gait coordination
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
measure: Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
measure: Automated Neuropsychological Assessment Metrics (ANAM)
timeFrame: baseline
measure: Dizziness Handicap Index (DHI)
timeFrame: baseline
measure: PTSD Checklist
timeFrame: baseline
measure: Pain Location Inventory
timeFrame: baseline
measure: SIQR symptom Questionnaire
timeFrame: baseline
measure: Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire
timeFrame: Every session
measure: Becks Depression Inventory (BDI)
timeFrame: baseline
measure: Short Form - 36
timeFrame: baseline
measure: Neurobehavioral Symptom Inventory
timeFrame: baseline
measure: Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vision
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
measure: Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vestibular
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
measure: Change in Central Sensorimotor Integration (CSMI) Weighting Scores; proprioception
timeFrame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Associate Professor of Neurology, OHSU
name: Laurie King, Ph.D., P.T.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.