Randomized Controlled Trial for Vestibular Treatment in Concussion

NCT ID: NCT03600324

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2024-08-31

Brief Summary

A prospective, single-blind, four-group multi-center randomized controlled trial (RCT) of targeted rehabilitation exercises for vestibular symptoms and impairments (T-REV) in civilians with mild traumatic brain injury (mTBI) will be conducted at the University of Pittsburgh Medical Center Sports Medicine Concussion Program (UPitt). The four treatment groups will consist of the factorial combinations of low (30%) and high (70%) intensity of exercise crossed with low (12-18 min, 1x/day) and high (12-18 min, 2x/day) frequency. A total of 125 participants aged 18-50 years will be enrolled across years 1-4, with approximately 100 participants completing the whole study. After potential participants with mTBI are screened for the vestibular clinical profile, using domain-specific tests and measures, and enrolled into the study, participants will complete primary and secondary outcome measures and receive a home exercise program that a) targets participants individual deficits, and b) is of the appropriate intensity and frequency for the participant's randomly assigned treatment group. Participants will return for in-clinic visits once per week to receive treatment and progress assigned exercises.

Detailed Description

During the past 17 years, US military personnel experienced 305,000 mTBI (DVBIC, 2017), with an estimated 65% (187,000) involving some type of vestibular impairment (gaze, postural/dynamic instability) and symptoms (dizziness, vertigo, motion intolerance) (Mucha et al., 2014). These vestibular impairments and symptoms, which have been associated with poor outcomes following mTBI including longer recovery times (Lau et al., 2011), can be actively treated using targeted vestibular rehabilitation exercises (Alsalaheen et al., 2010). In fact, the investigators recently concluded an observational trial of military personnel and civilians with mTBI- Targeted Evaluation, Action and Monitoring of TBI (TEAM-TBI) project (W81XWH-14-2-0002) supporting the effectiveness of targeted vestibular rehabilitation exercises in military personnel and civilians with complex mTBI (Kontos et al., in press). Although these vestibular-focused rehabilitation exercises are commonly used by military medical personnel following complex mTBI, there are no well-designed studies that show how much these exercises should be performed to be effective in US military personnel. In short, the concussion rehabilitation field does not know how frequently or intensely the exercises should be performed in order for injured personnel to have the best recovery.

In the current proposal, the investigators leverage our interdisciplinary team of experts from physical therapy, neurology, neuropsychology, and sports medicine and over 17 years of clinical and research experience to conduct a RCT comparing different frequency and intensity of targeted vestibular therapeutic exercises in military personnel and civilians. In so doing, the proposed study may inform a more precise approach for treating vestibular symptoms and impairments following mTBI that minimizes morbidity and accelerates recovery. Deliverables from the current study include: 1) outcome data regarding the efficacy of different frequencies and intensities of targeted vestibular exercises in both military personnel and civilians, and 2) evidence-based clinical practice guidelines (CPG) for prescribing vestibular therapeutic exercises.

Conditions

Vestibular Disorder; Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low Intensity/Low Frequency

Participants will be assigned T-REV with low intensity (30% of perceived effort) and low frequency (exercises performed 1x/day)

Group Type: EXPERIMENTAL

T-REV

Intervention Type: BEHAVIORAL

For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

Low Intensity/ High Frequency

Participants will be assigned T-REV with low intensity (30% of perceived effort) and high frequency (exercises performed 2x/day)

Group Type: EXPERIMENTAL

T-REV

Intervention Type: BEHAVIORAL

For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

High Intensity/Low Frequency

Participants will be assigned T-REV with high intensity (70% of perceived effort) and low frequency (exercises performed 1x/day)

Group Type: EXPERIMENTAL

T-REV

Intervention Type: BEHAVIORAL

For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

High Intensity/High Frequency

Participants will be assigned T-REV with high intensity (70% of perceived effort) and high frequency (exercises performed 2x/day)

Group Type: EXPERIMENTAL

T-REV

Intervention Type: BEHAVIORAL

For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

Interventions

T-REV

For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-50 years of age
• Normal/corrected vision
• Diagnosed with sport-related mTBI/concussion in the past 8 days-1 year with clear mechanism of injury
• Glasgow coma scale (GCS) of 13 or greater
• Reported signs of mTBI including: loss of consciousness, amnesia, disorientation, confusion, dizziness, imbalance, memory problems, vomiting
• mTBI-related vestibular symptoms (dizziness, vertigo, motion intolerance) and/or impairments (gaze stabilization, standing balance, functional gait) per a comprehensive assessment, clinical exam, and interview

Exclusion Criteria

• History of vestibular disorder prior to current mTBI (benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction)
• Benign Paroxysmal Positional Vertigo (BPPV) resulting from vestibular hypofunction
• Dizziness symptoms that only result from exercise
• History of neurological disorder
• <1 month or >6 months following current mTBI
• Currently pregnant or become pregnant during study
• Currently involved in litigation associated with current or previous mTBI Note: history of motion sickness/sensitivity will NOT be excluded. We will adjust for any imbalance in groups on this factor by covariate analysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Anthony P. Kontos, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony P Kontos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Warrior Recovery Center

Colorado Springs, Colorado, United States

Naval Medical Center Camp Lejeune - Intrepid Spirit Concussion Recovery Center

Marine Corps Base Camp Lejeune, North Carolina, United States

UPMC/Univ of Pgh Sports Medicine Concussion Research Program

Pittsburgh, Pennsylvania, United States

Carl R. Darnall Army Medical Center - Intrepid Spirit Center

Fort Hood, Texas, United States

Countries

United States

Other Identifiers

PT170144

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO18070243

Identifier Type: -

Identifier Source: org_study_id