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Vestibular Treatment in Adolescents Following Sport Related Concussion

NCT03555370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-04

No results posted yet for this study

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.

Conditions

  • Vestibular Disorder

Interventions

BEHAVIORAL

Vestibular Exercise Intervention

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.

BEHAVIORAL

Standard of Care

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

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Anthony P Kontos, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2020-03-02
Completion
2020-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555370 on ClinicalTrials.gov