Vestibular ProblemNCT03441776
Towards Comparative Effectiveness in Military Vestibular Rehabilitation
A study testing Generalized Vestibular Rehabilitation Treatment and Individualized Vestibular Rehabilitation Treatment in people with Vestibular Problem and Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center at 1 site in United States.
Trial summary
To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Vestibular Problem, Traumatic Brain Injury
- What is being tested?
- Generalized Vestibular Rehabilitation Treatment and Individualized Vestibular Rehabilitation Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to Jul 2022
- 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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active Duty Service Member
- Referral to Warrior Recovery Center
- Need of treatment for gaze stabilization, static standing, balance, dynamic standing balance, gait, motion sensitivity, modified center of gravity, and/or work-related functional task training; determined by physical therapist
- Dizziness as identified by a score of 16 - 64 on DHI
- Personal history of Mild-Traumatic TBI occurring between 4 weeks and 5 years from the Pre-Treatment PT Evaluation Visit
- Fluency in English
Who cannot join
- Participation in a concurrent interventional trial
- History of Severe TBI
- Inability to participate in treatment visits or any of the research activities
- Any vestibular dysfunction that cannot be treated with a generalized treatment plan (e.g. benign paroxysmal positional vertigo, acute vestibular infection) as defined by PT discretion
- Any unstable and/or chronic medical or psychiatric condition that could confound the results of the study and/or place the participant at risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Warrior Recovery Center, Evans Army Community Hospital
Fort Carson, Colorado, 80913
About this study
To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms.
Read the detailed description
Aim 1. To prospectively evaluate the reliability of a series of diagnostic and outcome assessment tools in a military cohort with post-concussive vestibular symptoms; these to include the Dizziness Handicap Inventory (DHI), Activities-Specific Balance Confidence Scale (ABC), the Computerized Dynamic Posturography (CDP) and the Neuro-Otologic Test System (NOTC).
Hypothesis 1. Active military personnel consist of physically high functioning individuals in whom standard diagnostic and outcome assessment tools may fail to target variations in performance. The investigators believe that active military personnel score different than general populations in standard diagnostic and outcome assessment tools.
Endpoint 1. The investigators will compare the DHI, ABC, CDP and NOTC results obtained in this study with historical data from the studies supporting the validation of each of the individual assessment tools.
Aim 2. To assess the concept of 'clinically meaningful change' as it relates to dizziness specific to a military cohort with post-concussive vestibular symptoms.
Hypothesis 2. Because of the differences in physical characteristics and performance demands between active duty military personnel and the general population, it is difficult to define if changes in diagnostic and outcome assessment evaluations in the military population reflect worsening or progression of symptoms at the same rate and magnitude observed in the general population.
Endpoint 2. The investigators will establish a comparison among study test results (DHI, ABC, CDP and NOTC) and compare these to clinical measures of response to treatment (Neurobehavioral Symptom Inventory - vestibular domain and Patients' Global Impression of Change Scale) to identify the rate and magnitude of change in the military cohort.
Aim 3. To compare scoring differences between subjects receiving individualized vestibular rehabilitation treatment (IVRT) and subjects receiving generalized vestibular rehabilitation treatment (GVRT), and to calculate the magnitude of change or the lack of it to determine the sample size for a subsequent comparative effectiveness trial.
Hypothesis 3. The combination of tests used in this study has not been used before; therefore, no data is available to calculate the sample size needed to determine comparative effectiveness between GVRT vs IVRT using DHI, ABC, CDP and NOTC.
Endpoint 3. The investigators will compare DHI, ABC, CDP and NOTC measurement results between treatment groups to estimate normal variation.
Aim 4. To refine methods, procedures, and information parameters for a comparative effectiveness trial assessing individualized vs. generalized vestibular rehabilitation therapy.
Endpoint 4. The investigators will evaluate and compare different elements inherent to the trial such as mechanisms of subject identification, evaluation times and tolerance, information tracking, etc. along with data obtained through the Patient Satisfaction Survey (PSS).
- Conditions
- Vestibular Problem, Traumatic Brain Injury
- Being tested
- Generalized Vestibular Rehabilitation Treatment, Individualized Vestibular Rehabilitation Treatment
- Keywords
- TBI, Rehabilitation, Vestibular, Dizziness
- Medical subject headings
- Vestibular Diseases, Brain Injuries, Traumatic, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generalized Vestibular Rehabilitation TreatmentOther
Also called GVRT
These treatment visits are available twice a week and each visit lasts 45 minutes. Individuals receiving GVRT are allowed to choose the frequency at which they want to attend and the program is designed for each subject to complete 8 visits within a period between 4 and 8 weeks. The ideal number of patients receiving treatment at each class is from 3 to 6 but the system has capacity for a maximum of 8. GVRT is a standard of care treatment option and is not considered research.
Individualized Vestibular Rehabilitation TreatmentOther
Also called IVRT
Individuals receiving IVRT are scheduled depending on their individual needs and PT availability. These visits require one-on-one time with a PT. Individuals are commonly seen by the PT 3 times at two week intervals. These visits last 30 minutes and include PT evaluation designed to instruct patients on exercises for them to perform on their own. IVRT is a standard of care treatment option and is not considered research.
| Study group | Role | What they receive |
|---|---|---|
| Randomized GVRT | Other | Randomized Generalized Vestibular Rehabilitation Treatment (8 treatments) as part of standard of care (not research visits) Receives: Other: Generalized Vestibular Rehabilitation Treatment |
| Randomized IVRT | Other | Randomized Individualized Vestibular Rehabilitation Treatment (3 treatments) as part of standard of care (not research visits) Receives: Other: Individualized Vestibular Rehabilitation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dizziness Handicap Inventory (DHI) score
Self reported perception of handicap related to dizziness. 25 questions. Each item is scored 0 - 4 (0 = no, 2 = sometimes, 4 = always), yielding a total score between 0 (no perceived disability) and 100 (maximum perceived disability). Subscales related to certain questions are describes as physical, emotional and functional disabilities.
Measured: Baseline and 2 weeks after final treatment visit
Secondary outcomes (8)
Change in Activities-specific Balance Confidence (ABC) Scale
Self reported level of confidence of not losing balance or becoming unsteady during specific activities. Participants rate their perceived confidence on a 0-100% scale (0% = no confidence, 100% = completely confident). Total score is averaged percentage of 16 questions.
Measured: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Sensory Organization Test (SOT)
Equilibrium score quantifies postural stability during each of 3 trials of 6 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Measured: Baseline and 2 weeks after final treatment visit
Change in Composite Equilibrium Score on Sensory Organization Test (SOT)
Composite Equilibrium Score is averaged from the six SOT Equilibrium Scores. Equilibrium score quantifies postural stability during each of 3 trials of 6 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Measured: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)
Equilibrium score quantifies postural stability with horizontal head movement during each of 3-4 trials of 2 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Measured: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)
Equilibrium Score Ratio compares the average Equilibrium Score between the SOT and HS-SOT relating to the same sensory conditions. Equilibrium score quantifies postural stability during each of 3-4 trials of 2 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Measured: Baseline and 2 weeks after final treatment visit
Change in logMAR (Visual Acuity) during horizontal head movement (Dynamic Visual Acuity)
logMAR is given for positive and negative responses during left movement and right movement. logMAR is a unit describing the apparent size of an image based on a ratio of its absolute size to distance from the eye.
Measured: Baseline and 2 weeks after final treatment visit
Change in logMAR (Visual Acuity) during vertical head movement (Dynamic Visual Acuity)
logMAR is given for positive and negative responses during up movement and down movement. logMAR is a unit describing the apparent size of an image based on a ratio of its absolute size to distance from the eye.
Measured: Baseline and 2 weeks after final treatment visit
Change in Neuro-Otologic Testing
Gaze Horizontal, Random Saccades Horizontal and Vertical, Smooth Pursuit Horizontal 0.1Hz and 0.75Hz, Smooth Pursuit Vertical 0.1Hz and 0.75Hz, Predictive Saccades Horizontal, Antisaccades, OKN Trap 20deg/sec and 60deg/sec, Visual Reaction Time, Saccade and Reaction Time, Auditory Reaction Time, Chair Rotation Sinusoidal 0.02Hz, 0.08Hz and 0.64Hz, Visual Enhancement, Visual Suppression, Step Test, Subjective Visual Vertical, crHIT
Measured: Baseline and 2 weeks after final treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start9 Feb 2018
- Primary completion2 Jun 2020
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular ProblemStudies of the same condition, open and under way.
- 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
- Model description
- This is a single site, randomized, open label, pilot study to test the environment, resources and tools required to perform a comparative effectiveness trial assessing two different standard of care vestibular rehabilitation approaches.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Defense and Veterans Brain Injury Center
- Sponsor type
- US federal agency
- Collaborators
- Evans Army Community Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441776
- Sponsor's protocol ID
- RHC-A-18-006
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2018
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Comparative Effectiveness in Military Vestibular Rehabilitation
- ClinicalTrials.gov ID
- NCT03441776
- Acronym / sponsor ID
- RHC-A-18-006
- Conditions
- Vestibular Problem, Traumatic Brain Injury
- Keywords
- TBI, Rehabilitation, Vestibular, Dizziness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The Defense and Veterans Brain Injury CenterUS federal agency
- Collaborators
- Evans Army Community Hospital
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- Jul 2022 (estimated)
- First posted
- 22 Feb 2018 (actual)
- 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.
To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms.
Detailed description
Aim 1. To prospectively evaluate the reliability of a series of diagnostic and outcome assessment tools in a military cohort with post-concussive vestibular symptoms; these to include the Dizziness Handicap Inventory (DHI), Activities-Specific Balance Confidence Scale (ABC), the Computerized Dynamic Posturography (CDP) and the Neuro-Otologic Test System (NOTC).
Hypothesis 1. Active military personnel consist of physically high functioning individuals in whom standard diagnostic and outcome assessment tools may fail to target variations in performance. The investigators believe that active military personnel score different than general populations in standard diagnostic and outcome assessment tools.
Endpoint 1. The investigators will compare the DHI, ABC, CDP and NOTC results obtained in this study with historical data from the studies supporting the validation of each of the individual assessment tools.
Aim 2. To assess the concept of 'clinically meaningful change' as it relates to dizziness specific to a military cohort with post-concussive vestibular symptoms.
Hypothesis 2. Because of the differences in physical characteristics and performance demands between active duty military personnel and the general population, it is difficult to define if changes in diagnostic and outcome assessment evaluations in the military population reflect worsening or progression of symptoms at the same rate and magnitude observed in the general population.
Endpoint 2. The investigators will establish a comparison among study test results (DHI, ABC, CDP and NOTC) and compare these to clinical measures of response to treatment (Neurobehavioral Symptom Inventory - vestibular domain and Patients' Global Impression of Change Scale) to identify the rate and magnitude of change in the military cohort.
Aim 3. To compare scoring differences between subjects receiving individualized vestibular rehabilitation treatment (IVRT) and subjects receiving generalized vestibular rehabilitation treatment (GVRT), and to calculate the magnitude of change or the lack of it to determine the sample size for a subsequent comparative effectiveness trial.
Hypothesis 3. The combination of tests used in this study has not been used before; therefore, no data is available to calculate the sample size needed to determine comparative effectiveness between GVRT vs IVRT using DHI, ABC, CDP and NOTC.
Endpoint 3. The investigators will compare DHI, ABC, CDP and NOTC measurement results between treatment groups to estimate normal variation.
Aim 4. To refine methods, procedures, and information parameters for a comparative effectiveness trial assessing individualized vs. generalized vestibular rehabilitation therapy.
Endpoint 4. The investigators will evaluate and compare different elements inherent to the trial such as mechanisms of subject identification, evaluation times and tolerance, information tracking, etc. along with data obtained through the Patient Satisfaction Survey (PSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single site, randomized, open label, pilot study to test the environment, resources and tools required to perform a comparative effectiveness trial assessing two different standard of care vestibular rehabilitation approaches.
| Arm | Type | Receives |
|---|---|---|
| Randomized GVRT | Other | Other: Generalized Vestibular Rehabilitation TreatmentRandomized Generalized Vestibular Rehabilitation Treatment (8 treatments) as part of standard of care (not research visits) |
| Randomized IVRT | Other | Other: Individualized Vestibular Rehabilitation TreatmentRandomized Individualized Vestibular Rehabilitation Treatment (3 treatments) as part of standard of care (not research visits) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Active Duty Service Member
- Referral to Warrior Recovery Center
- Need of treatment for gaze stabilization, static standing, balance, dynamic standing balance, gait, motion sensitivity, modified center of gravity, and/or work-related functional task training; determined by physical therapist
- Dizziness as identified by a score of 16 - 64 on DHI
- Personal history of Mild-Traumatic TBI occurring between 4 weeks and 5 years from the Pre-Treatment PT Evaluation Visit
Key exclusion criteria (5 listed)
- Participation in a concurrent interventional trial
- History of Severe TBI
- Inability to participate in treatment visits or any of the research activities
- Any vestibular dysfunction that cannot be treated with a generalized treatment plan (e.g. benign paroxysmal positional vertigo, acute vestibular infection) as defined by PT discretion
- Any unstable and/or chronic medical or psychiatric condition that could confound the results of the study and/or place the participant at risk
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 |
|---|---|---|
| Generalized Vestibular Rehabilitation TreatmentAlso: GVRTThese treatment visits are available twice a week and each visit lasts 45 minutes. Individuals receiving GVRT are allowed to choose the frequency at which they want to attend and the program is designed for each subject to complete 8 visits within a period between 4 and 8 weeks. The ideal number of patients receiving treatment at each class is from 3 to 6 but the system has capacity for a maximum of 8. GVRT is a standard of care treatment option and is not considered research. | Other | Randomized GVRT |
| Individualized Vestibular Rehabilitation TreatmentAlso: IVRTIndividuals receiving IVRT are scheduled depending on their individual needs and PT availability. These visits require one-on-one time with a PT. Individuals are commonly seen by the PT 3 times at two week intervals. These visits last 30 minutes and include PT evaluation designed to instruct patients on exercises for them to perform on their own. IVRT is a standard of care treatment option and is not considered research. | Other | Randomized IVRT |
Primary outcome
Change in Dizziness Handicap Inventory (DHI) score
Time frame: Baseline and 2 weeks after final treatment visit
Self reported perception of handicap related to dizziness. 25 questions. Each item is scored 0 - 4 (0 = no, 2 = sometimes, 4 = always), yielding a total score between 0 (no perceived disability) and 100 (maximum perceived disability). Subscales related to certain questions are describes as physical, emotional and functional disabilities.
8 secondary outcomes
Change in Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Sensory Organization Test (SOT)
Time frame: Baseline and 2 weeks after final treatment visit
Change in Composite Equilibrium Score on Sensory Organization Test (SOT)
Time frame: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)
Time frame: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)
Time frame: Baseline and 2 weeks after final treatment visit
Change in logMAR (Visual Acuity) during horizontal head movement (Dynamic Visual Acuity)
Time frame: Baseline and 2 weeks after final treatment visit
Change in logMAR (Visual Acuity) during vertical head movement (Dynamic Visual Acuity)
Time frame: Baseline and 2 weeks after final treatment visit
Change in Neuro-Otologic Testing
Time frame: Baseline and 2 weeks after final treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generalized Vestibular Rehabilitation Treatment and Individualized Vestibular Rehabilitation Treatment in people with Vestibular Problem and Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 2022. 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?
Results are not available in the source record.
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 Dizziness Handicap Inventory (DHI) score (time frame: Baseline and 2 weeks after final treatment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2022.