Towards Comparative Effectiveness in Military Vestibular Rehabilitation

NCT03441776 | Unknown

• 1 other identifier: RHC-A-18-006
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Problem; Traumatic Brain Injury

Keywords

TBI; Rehabilitation; Vestibular; Dizziness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Activities-specific Balance Confidence (ABC) Scale

  Baseline and 2 weeks after final treatment visit

• Change in Equilibrium Score on Sensory Organization Test (SOT)

  Baseline and 2 weeks after final treatment visit

• Change in Composite Equilibrium Score on Sensory Organization Test (SOT)

  Baseline and 2 weeks after final treatment visit

• Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)

  Baseline and 2 weeks after final treatment visit

• Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)

  Baseline and 2 weeks after final treatment visit

Study Arms (2)

Randomized GVRT

OTHER

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

Other: Generalized Vestibular Rehabilitation Treatment

Randomized IVRT

OTHER

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

Other: Individualized Vestibular Rehabilitation Treatment

Interventions

Generalized Vestibular Rehabilitation Treatment 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.

Also known as: GVRT

Randomized GVRT

Individualized Vestibular Rehabilitation Treatment 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.

Also known as: IVRT

Randomized IVRT

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Defense and Veterans Brain Injury Center: lead
• Evans Army Community Hospital: collaborator

Study Sites (1)

Warrior Recovery Center, Evans Army Community Hospital

Fort Carson, Colorado, 80913, United States

Location

MeSH Terms

Conditions

Vestibular Diseases; Brain Injuries, Traumatic; Dizziness

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: February 9, 2018
• Primary Completion: June 2, 2020
• Study Completion: July 1, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)