Randomized Controlled Trial for Vestibular Treatment in Concussion

Completed · Not applicable

Conditions studied: Vestibular Disorder, Mild Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT03600324

Run by

University of Pittsburgh

People needed

121

Starts

2020-02-26

Expected to finish

2024-08-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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