Towards Comparative Effectiveness in Military Vestibular Rehabilitation

Traumatic Brain Injury Clinical Trial

Official title:

Towards Comparative Effectiveness in Military Vestibular Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03441776
• Other study ID #: RHC-A-18-006
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: July 2022

Study information

• Verified date: March 2022
• Source: The Defense and Veterans Brain Injury Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: July 2022
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Vestibular Problem

Intervention

Other:
• Generalized Vestibular Rehabilitation Treatment
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 Treatment
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.

Locations

Country	Name	City	State
United States	Warrior Recovery Center, Evans Army Community Hospital	Fort Carson	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
The Defense and Veterans Brain Injury Center	Evans Army Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 2 weeks after final treatment visit
Secondary	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.	Baseline and 2 weeks after final treatment visit
Secondary	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).	Baseline and 2 weeks after final treatment visit
Secondary	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).	Baseline and 2 weeks after final treatment visit
Secondary	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).	Baseline and 2 weeks after final treatment visit
Secondary	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).	Baseline and 2 weeks after final treatment visit
Secondary	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.	Baseline and 2 weeks after final treatment visit
Secondary	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.	Baseline and 2 weeks after final treatment visit
Secondary	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	Baseline and 2 weeks after final treatment visit