Towards Comparative Effectiveness in Military Vestibular Rehabilitation

NCT ID: NCT03441776

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2022-07-31

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).

Conditions

Vestibular Problem; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized GVRT

Randomized Generalized Vestibular Rehabilitation Treatment (8 treatments) as part of standard of care (not research visits)

Group Type: OTHER

Generalized Vestibular Rehabilitation Treatment

Intervention Type: OTHER

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.

Randomized IVRT

Randomized Individualized Vestibular Rehabilitation Treatment (3 treatments) as part of standard of care (not research visits)

Group Type: OTHER

Individualized Vestibular Rehabilitation Treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

GVRT; IVRT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evans Army Community Hospital

OTHER

Sponsor Role: collaborator

The Defense and Veterans Brain Injury Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Warrior Recovery Center, Evans Army Community Hospital

Fort Carson, Colorado, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

RHC-A-18-006

Identifier Type: -

Identifier Source: org_study_id