Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
Primary Purpose
Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Rehabilitation + audio biofeedback
Vestibular Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury focused on measuring Physical Therapy, Balance Disorder, Concussion, Mild Traumatic Brain Injury
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)
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vestibular Rehabilitation + audio biofeedback
Vestibular Rehabilitation
Arm Description
Vestibular rehabilitation paired with audio biofeedback
Vestibular rehabilitation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Sensory Orientation Test (SOT) Composite Score
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.
Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores
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.
Change in dynamic gait coordination
We will compare baseline gait measures using inertial sensors looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire
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.
Automated Neuropsychological Assessment Metrics (ANAM)
We will use this test to determine if it is a good predictor for rehabilitation outcomes
Dizziness Handicap Index (DHI)
This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.
PTSD Checklist
This questionnaire takes approximately 10 minutes and is a list of problems and complaints some people have in response to stressful life experiences.
Pain Location Inventory
This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.
SIQR symptom Questionnaire
This questionnaire asks you to rate different symptoms on a sliding scale.
Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire
This questionnaire takes approximately 5 minutes and asks you to rate 22 different symptoms on a scale between zero and six.
Becks Depression Inventory (BDI)
This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.
Short Form - 36
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.
Neurobehavioral Symptom Inventory
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.
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vision
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.
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vestibular
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.
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; proprioception
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.
Full Information
NCT ID
NCT02748109
First Posted
March 29, 2016
Last Updated
March 10, 2021
Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02748109
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
June 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
Physical Therapy, Balance Disorder, Concussion, Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vestibular Rehabilitation + audio biofeedback
Arm Type
Experimental
Arm Description
Vestibular rehabilitation paired with audio biofeedback
Arm Title
Vestibular Rehabilitation
Arm Type
Active Comparator
Arm Description
Vestibular rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Rehabilitation + audio biofeedback
Intervention Description
Vestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
Standard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks.
Primary Outcome Measure Information:
Title
Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention.
Description
An APDM movement monitor will be worn around the waist to gather information on local activity during the day.
Time Frame
before and after 6 weeks of intervention
Secondary Outcome Measure Information:
Title
Change in Sensory Orientation Test (SOT) Composite Score
Description
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.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Title
Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores
Description
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.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Title
Change in dynamic gait coordination
Description
We will compare baseline gait measures using inertial sensors looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Title
Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire
Description
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.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Title
Automated Neuropsychological Assessment Metrics (ANAM)
Description
We will use this test to determine if it is a good predictor for rehabilitation outcomes
Time Frame
baseline
Title
Dizziness Handicap Index (DHI)
Description
This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.
Time Frame
baseline
Title
PTSD Checklist
Description
This questionnaire takes approximately 10 minutes and is a list of problems and complaints some people have in response to stressful life experiences.
Time Frame
baseline
Title
Pain Location Inventory
Description
This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.
Time Frame
baseline
Title
SIQR symptom Questionnaire
Description
This questionnaire asks you to rate different symptoms on a sliding scale.
Time Frame
baseline
Title
Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire
Description
This questionnaire takes approximately 5 minutes and asks you to rate 22 different symptoms on a scale between zero and six.
Time Frame
Every session
Title
Becks Depression Inventory (BDI)
Description
This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.
Time Frame
baseline
Title
Short Form - 36
Description
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.
Time Frame
baseline
Title
Neurobehavioral Symptom Inventory
Description
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.
Time Frame
baseline
Title
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vision
Description
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.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Title
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vestibular
Description
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.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Title
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; proprioception
Description
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.
Time Frame
Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie King, Ph.D., P.T.
Organizational Affiliation
Associate Professor of Neurology, OHSU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33011672
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.
Results Reference
background
PubMed Identifier
31783306
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.
Results Reference
background
PubMed Identifier
32495691
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.
Results Reference
background
PubMed Identifier
31354032
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.
Results Reference
background
PubMed Identifier
30619027
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.
Results Reference
background
PubMed Identifier
30045224
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.
Results Reference
background
PubMed Identifier
29078732
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.
Results Reference
background
PubMed Identifier
28231824
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.
Results Reference
background
PubMed Identifier
32941367
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.
Results Reference
background
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Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
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