Clinical trial NCT03441776: Towards Comparative Effectiveness in Military Vestibular Rehabilitation
Official title: Towards Comparative Effectiveness in Military Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Problem
Traumatic Brain Injury
Keywords: TBI
Rehabilitation
Vestibular
Dizziness
Lead sponsor: The Defense and Veterans Brain Injury Center
Sponsor class: FED
Collaborators: name: Evans Army Community Hospital
First posted: 2018-02-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Dizziness Handicap Inventory (DHI) score
timeFrame: Baseline and 2 weeks after final treatment visit
Secondary outcomes:
measure: Change in Activities-specific Balance Confidence (ABC) Scale
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in Equilibrium Score on Sensory Organization Test (SOT)
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in Composite Equilibrium Score on Sensory Organization Test (SOT)
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in logMAR (Visual Acuity) during horizontal head movement (Dynamic Visual Acuity)
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in logMAR (Visual Acuity) during vertical head movement (Dynamic Visual Acuity)
timeFrame: Baseline and 2 weeks after final treatment visit
measure: Change in Neuro-Otologic Testing
timeFrame: Baseline and 2 weeks after final treatment visit
Other outcomes:
Locations:
city: Fort Carson
country: United States
facility: Warrior Recovery Center, Evans Army Community Hospital
state: Colorado
Study officials:
References: