NCT03555370

Vestibular Treatment in Adolescents Following Sport Related Concussion

Completed NA Last updated 4 March 2020

What this trial tests

NA trial testing Vestibular Exercise Intervention in Vestibular Disorder in 50 participants. Completed in 2 March 2020.

Timeline

18 October 2018

Primary endpoint
2 March 2020

2 March 2020

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	50
Start date	18 October 2018
Primary completion	2 March 2020
Estimated completion	2 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Vestibular Exercise Intervention
• Standard of Care

Conditions studied

• Vestibular Disorder — all drugs for Vestibular Disorder →

Sponsor

University of Pittsburgh

Who can join

Adults 12 to 18, any sex, with Vestibular Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial of Precision Vestibular Rehabilitation in Adolescents following Concussion: Preliminary Findings.
   Kontos AP, Eagle SR, Mucha A, Kochick V, et al · · 2021 · cited 45× · PMID 34450120 · DOI 10.1016/j.jpeds.2021.08.032