Towards Comparative Effectiveness in Military Vestibular Rehabilitation
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 2/27/2019 |
Start Date: | February 9, 2018 |
End Date: | February 2019 |
Contact: | Candace A Pearson, RN, BSN, CCRC |
Email: | candace.a.pearson2.ctr@mail.mil |
Phone: | (719) 251-0696 |
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.
of two different standard of care vestibular rehabilitation approaches in a military cohort
with post-concussive vestibular symptoms.
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).
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).
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
We found this trial at
1
site
1650 Cochrane Circle
Fort Carson, Colorado 80913
Fort Carson, Colorado 80913
Principal Investigator: Alicia Souvingier, DPT
Phone: 719-251-0696
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