CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Vestibular Exercise Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03555370
NCT03555370N/ACompleted

RCT of Vestibular Treatment in Adolescents Following Sport Related Concussion

University of Pittsburgh·interventional·Posted Jun 13, 2018·Updated Mar 4, 2020

In Brief

A clinical study evaluating Vestibular Exercise Intervention and Standard of Care for Vestibular Disorder. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Each year, nearly 2 million children and adolescents have a sport-related concussion (SRC) in the U.S., but 57% of them do not receive appropriate clinical care following their injury. These injuries involve a wide range of symptoms including headache, dizziness, and sleep problems; and cognitive, emotional, visual, and vestibular impairment. The investigators have developed a clinical treatment model for SRC that addresses the heterogeneity of this injury using different clinical subtypes or profiles that inform precision interventions. To date, the investigators have identified cognitive, anxiety/mood, post-traumatic migraine, cervical, oculomotor, and vestibular clinical profiles. Patients with vestibular clinical profiles- involving dizziness, environmental sensitivity, and imbalance- are common (60-65% of concussions), and have worse outcomes and longer recovery following SRC. Consequently, the investigators have developed and applied precision vestibular treatments that can be matched to specific impairments and symptoms to actively treat patients with vestibular clinic profiles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 13, 2018
Enrollment StartOct 18, 2018
Primary CompletionMar 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.1 years ago

Interventions

Vestibular Exercise Interventionbehavioral

The vestibular exercise intervention group will complete behavioral management activities, and prescribed in--office/at home vestibular exercises from four groups: 1) gaze stability training (integrated eye and head movements on fixed target), 2) visual motion training (integrated eye and head movements on moving target), 3) standing balance (standing with eyes closed in different stances), and 4) dynamic gait (walking with head turns and eye movements). Participants will be prescribed to one of four levels of these exercise groups based on presentation of symptoms/impairment as indicated on VOMS. Progression through the levels will be based on symptom tolerance and successful completion of all exercises at the current level.

Standard of Carebehavioral

The standard of care consists of standardized in office/at home behavioral management including sleep, hydration, nutrition, and stress management interventions.