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Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI

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ClinicalTrials.gov Identifier: NCT02748109
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Laurie King, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Brain Injury Behavioral: Vestibular Rehabilitation + audio biofeedback Behavioral: Vestibular Rehabilitation Not Applicable

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 21 and 50; 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vestibular Rehabilitation + audio biofeedback
Vestibular rehabilitation paired with audio biofeedback
Behavioral: Vestibular Rehabilitation + audio biofeedback
Vestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks.

Active Comparator: Vestibular Rehabilitation
Vestibular rehabilitation
Behavioral: Vestibular Rehabilitation
Standard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks.




Primary Outcome Measures :
  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. [ Time Frame: before and after 6 weeks of intervention ]
    An APDM movement monitor will be worn around the waist to gather information on local activity during the day.


Secondary Outcome Measures :
  1. Change in Sensory Orientation Test (SOT) Composite Score [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline SOT composite score with the post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.

  2. Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline mBESS measures using inertial sensors and the clinical scoring method looking for a difference between the standard of care and audio biofeedback rehabilitation groups.

  3. Change in dynamic gait coordination [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline gait measures using inertial sensors looking for a difference between the standard of care and audio biofeedback rehabilitation groups.

  4. Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare subjects symptoms using the SCAT-3 symptom log looking for a difference between the standard of care and audio biofeedback rehabilitation groups.

  5. Automated Neuropsychological Assessment Metrics (ANAM) [ Time Frame: baseline ]
    We will use this test to determine if it is a good predictor for rehabilitation outcomes

  6. Dizziness Handicap Index (DHI) [ Time Frame: baseline ]
    This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.

  7. PTSD Checklist [ Time Frame: baseline ]
    This questionnaire takes approximately 10 minutes and is a list of problems and complaints some people have in response to stressful life experiences.

  8. Pain Location Inventory [ Time Frame: baseline ]
    This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.

  9. SIQR symptom Questionnaire [ Time Frame: baseline ]
    This questionnaire asks you to rate different symptoms on a sliding scale.

  10. Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire [ Time Frame: Every session ]
    This questionnaire takes approximately 5 minutes and asks you to rate 22 different symptoms on a scale between zero and six.

  11. Becks Depression Inventory (BDI) [ Time Frame: baseline ]
    This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.

  12. Short Form - 36 [ Time Frame: baseline ]
    This questionnaire will take approximately 10 minutes and covers 36 questions about daily living and how your symptoms have or have not changed over certain time periods.

  13. Neurobehavioral Symptom Inventory [ Time Frame: baseline ]
    This questionnaire takes approximately 10 minutes and goes through commons symptoms after traumatic brain injury (such as nausea and blurred vision) and asks you to rate your symptoms.

  14. Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vision [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline CSMI scores (Wvis) with post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.

  15. Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vestibular [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline CSMI scores (Wvest) with post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.

  16. Change in Central Sensorimotor Integration (CSMI) Weighting Scores; proprioception [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline CSMI scores (Wprop) with post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748109


Contacts
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Contact: Alexa Beeson, B.S. 503-418-2602 beesona@ohsu.edu
Contact: Nicholas Kreter, B.S. 503-418-2602 kreter@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Laurie King, PhD    503-418-2602    kingla@ohsu.edu   
Sub-Investigator: Robert Peterka, PhD         
Sub-Investigator: Timothy Hullar, MD         
Sub-Investigator: Jim Chesnutt, MD         
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center
Investigators
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Principal Investigator: Laurie King, Ph.D., P.T. Associate Professor of Neurology, OHSU

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laurie King, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02748109     History of Changes
Other Study ID Numbers: 15010
CDMRP-MR141257 ( Other Grant/Funding Number: Department of Defense )
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Laurie King, Oregon Health and Science University:
Physical Therapy
Balance Disorder
Concussion
Mild Traumatic Brain Injury

Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Hypesthesia
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms