- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441776
Towards Comparative Effectiveness in Military Vestibular Rehabilitation
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Carson, Colorado, United States, 80913
- Warrior Recovery Center, Evans Army Community Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Randomized GVRT
Randomized Generalized Vestibular Rehabilitation Treatment (8 treatments) as part of standard of care (not research visits)
|
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.
Other Names:
|
Other: Randomized IVRT
Randomized Individualized Vestibular Rehabilitation Treatment (3 treatments) as part of standard of care (not research visits)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 2 weeks after final treatment visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Activities-specific Balance Confidence (ABC) Scale
Time Frame: Baseline and 2 weeks after final treatment visit
|
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.
|
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
|
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).
|
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
|
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).
|
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
|
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).
|
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
|
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).
|
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
|
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.
|
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
|
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.
|
Baseline and 2 weeks after final treatment visit
|
Change in Neuro-Otologic Testing
Time Frame: Baseline and 2 weeks after final treatment visit
|
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
|
Baseline and 2 weeks after final treatment visit
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHC-A-18-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
First Affiliated Hospital Xi'an Jiaotong UniversityXijing Hospital; Second Affiliated Hospital of Wenzhou Medical University; Central... and other collaboratorsRecruitingMTBI - Mild Traumatic Brain Injury | Moderate Traumatic Brain InjuryChina
Clinical Trials on Generalized Vestibular Rehabilitation Treatment
-
Norwegian University of Science and TechnologyHaukeland University Hospital; St. Olavs HospitalCompletedNausea | Dizziness | Vestibular Diseases | NystagmusNorway
-
University of JaenCompletedPeripheral Vestibular DisorderSpain
-
Oregon Health and Science UniversityPortland VA Medical CenterCompletedBrain InjuryUnited States
-
National Cheng Kung UniversityRecruiting
-
Walsh UniversityAmerican Academy of Orthopaedic Manual Physical Therapists; Kent State University and other collaboratorsCompletedDizziness | Brain ConcussionUnited States
-
Maria Jesus Casuso-HolgadoNot yet recruitingQuality of Life | Multiple Sclerosis | Fatigue | Dizziness | Vestibular Disease | Usability | Balance Disorders | CybersicknessSpain
-
University of British ColumbiaNot yet recruitingLabyrinthitis | Benign Paroxysmal Positional Vertigo | Vestibular Neuronitis | Meniere Disease | Vestibular Neuritis | Herpes Zoster Oticus | Peripheral Vestibular Disorder
-
Boston Children's HospitalCompletedVestibular DiseasesUnited States
-
Ege UniversityCompletedVestibular Disorder | Peripheral Vestibular DisorderTurkey