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Completed

NCT Number: NCT03555370

Vestibular Treatment in Adolescents Following Sport Related Concussion

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.

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Key information

Conditions

Vestibular Disorder Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Ear Diseases Head Injuries, Closed Labyrinth Diseases Nervous System Diseases Otorhinolaryngologic Diseases Trauma, Nervous System Vestibular Diseases Wounds and Injuries Wounds, Nonpenetrating

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMPC Sports Medicine Concussion Research Program

Pittsburgh, Pennsylvania, 15203, United States

About this study

To determine using a RCT design the effectiveness of standard of care behavioral management (i.e., sleep, walking, nutrition, stress management) to standard of care behavioral management (i.e., sleep, walking, nutrition, stress management) (STANDARD OF CARE) plus vestibular exercises (i.e., balance, eye-head movements, and dynamic walking exercises) (VESTIBULAR) for reducing recovery time, symptoms, and vestibular (balance, eye-head movements) and cognitive (e.g., memory, processing speed) impairment in adolescent patients with vestibular clinical profiles following sport--related concussion (SRC).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 12-18 years of age.
  • Must be diagnosed with a sport-related concussion within the last 3-10 days.
  • Must be identified by UPMC Sports Medicine clinicians as having clinical presentation of a vestibular profile of concussion.
  • Must report an increase of +2 of symptom provocation on VOMS (from baseline symptom report) on either VOR or VMS measurements during VOMS assessment.

Exclusion criteria

  • More than 3 concussions including presenting injury;
  • Current history or pre-existing vestibular disorder;
  • Current orthopaedic injury;
  • History of brain surgery or TBI (based on Glasgow Coma Scale of <13);
  • History of substance abuse;
  • History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations);
  • Current concussion is non-sport related.

The above exclusion factors are known to influence recovery and thus if any one exclusion criterion is met, the athlete will be unable to participate in the current study.

Treatment and study plan

Vestibular Exercise Intervention

Behavioral

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 Care

Behavioral

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

Primary outcomes

  1. Change in VOMS Scores (Vestibular Ocular Motor Screening) from Baseline to 4 Week/Visit 2

    Time frame: Measures will be conducted at enrollment (within 10 days of injury) and at 2 weeks (+ or - 5 days) and 4 weeks (+ or - 5 days) following treatment.

    The VOMS assesses vestibular and ocular motor impairment via patient-reported symptom provocation brief assessments in 7 components: 1) smooth pursuits; 2, 3) horizontal and vertical saccades; 4) near point convergence (NPC); 5, 6) horizontal and vertical vestibular ocular reflex (VOR), and 7) visual motion sensitivity (VMS). Patients rate changes in headache, dizziness, nausea, and fogginess symptoms compared to immediate pre-assessment state on a scale of 0 (no symptoms) to 10 (severe symptoms) following each VOMS assessment to determine if each assessment provokes symptoms. Convergence is assessed by both symptom report and objective measurement of NPC distance, values are averaged across 3 trials. The VOMS takes approximately 5 min to administer.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

RCT of Vestibular Treatment in Adolescents Following Sport Related Concussion

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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