Brain InjuryNCT02748109
Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
A study testing Vestibular Rehabilitation + audio biofeedback and Vestibular Rehabilitation in people with Brain Injury, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury
- What is being tested?
- Vestibular Rehabilitation + audio biofeedback and Vestibular Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2016to 24 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Brain Injury
- Being tested
- Vestibular Rehabilitation + audio biofeedback, Vestibular Rehabilitation
- Keywords
- Physical Therapy, Balance Disorder, Concussion, Mild Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation + audio biofeedbackBehavioural
Vestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks.
Vestibular RehabilitationBehavioural
Standard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation + audio biofeedback | Experimental | Vestibular rehabilitation paired with audio biofeedback Receives: Behavioral: Vestibular Rehabilitation + audio biofeedback |
| Vestibular Rehabilitation | Active comparator | Vestibular rehabilitation Receives: Behavioral: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and after 6 weeks of intervention
Secondary outcomes (16)
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.
Measured: 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
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.
Measured: 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
We will compare baseline gait measures using inertial sensors looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
Measured: 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
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.
Measured: 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)
We will use this test to determine if it is a good predictor for rehabilitation outcomes
Measured: baseline
Dizziness Handicap Index (DHI)
This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.
Measured: baseline
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.
Measured: baseline
Pain Location Inventory
This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.
Measured: baseline
SIQR symptom Questionnaire
This questionnaire asks you to rate different symptoms on a sliding scale.
Measured: baseline
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.
Measured: Every session
Becks Depression Inventory (BDI)
This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
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.
Measured: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
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.
Measured: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start11 May 2016
- Primary completion11 Apr 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center
- Responsible party
- Principal investigator, Laurie King, Oregon Health and Science University
- Investigators
- Laurie King, Ph.D., P.T., Principal investigator, Associate Professor of Neurology, OHSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748109
- Sponsor's protocol ID
- 15010
- Other IDs
- CDMRP-MR141257
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2016
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33011672Stuart 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.
PubMed 31783306Martini 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.
PubMed 32495691Stuart 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.
PubMed 31354032Peterka 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.
PubMed 30619027Fino 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.
PubMed 30045224Fino 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.
PubMed 29078732Fino 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.
PubMed 28231824Theodoroff 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.
PubMed 32941367
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
- ClinicalTrials.gov ID
- NCT02748109
- Acronym / sponsor ID
- 15010
- Conditions
- Brain Injury
- Keywords
- Physical Therapy, Balance Disorder, Concussion, Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland VA Medical Center
- Study start
- 11 May 2016 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation + audio biofeedback | Experimental | Behavioral: Vestibular Rehabilitation + audio biofeedbackVestibular rehabilitation paired with audio biofeedback |
| Vestibular Rehabilitation | Active comparator | Behavioral: Vestibular RehabilitationVestibular rehabilitation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation + audio biofeedbackVestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks. | Behavioural | Vestibular Rehabilitation + audio biofeedback |
| Vestibular RehabilitationStandard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks. | Behavioural | Vestibular Rehabilitation |
Primary outcome
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.
16 secondary outcomes
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
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
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
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
Automated Neuropsychological Assessment Metrics (ANAM)
Time frame: baseline
Dizziness Handicap Index (DHI)
Time frame: baseline
PTSD Checklist
Time frame: baseline
Pain Location Inventory
Time frame: baseline
SIQR symptom Questionnaire
Time frame: baseline
Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire
Time frame: Every session
Becks Depression Inventory (BDI)
Time frame: baseline
Short Form - 36
Time frame: baseline
Neurobehavioral Symptom Inventory
Time frame: baseline
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 33011672Fino 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.
- Background: PubMed 31783306Stuart 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.
- Background: PubMed 32495691Martini 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.
- Background: PubMed 31354032Stuart 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.
- Background: PubMed 30619027Peterka 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.
- Background: PubMed 30045224Fino 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.
- Background: PubMed 29078732Fino 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.
- Background: PubMed 28231824Fino 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.
- Background: PubMed 32941367Theodoroff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie King, Ph.D., P.T. principal investigator
Associate Professor of Neurology, OHSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation + audio biofeedback and Vestibular Rehabilitation in people with Brain Injury, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: before and after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748109, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.