Vestibular Treatment in Adolescents Following Sport Related Concussion

March 3, 2020 updated by: Anthony P. Kontos, Ph.D., University of Pittsburgh

RCT of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15203
        • UMPC Sports Medicine Concussion Research Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Standard of Care Group

Standard of Care:

The standard of care protocol consists of standardized in office and at home behavioral management to include sleep, hydration, nutrition, and stress management interventions. Participants will also be assigned physical activity that they will complete during their visits and at home. Physical activity for the standard of care group will include 15 minutes of flexibility/range of motion exercises, and 10 minutes of aerobic-based daily physical activity (e.g.,walking, stationary cycle).
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.
EXPERIMENTAL: Vestibular Exercise Intervention Group
The vestibular group will complete the behavioral management activities described above, as well as prescribed in-office and at home vestibular exercises from each of four groups: 1) gaze stability training (i.e., integrated eye and head movements on fixed target), 2) visual motion training (i.e., integrated eye and head movements with busy visual background), 3) standing balance (i.e., standing in different stances), and 4) dynamic gait (i.e., walking with head turns). Participants will be prescribed to one of four levels of these four exercise groups based on presentation of symptoms/impairment as indicated on the VOMS. Progression through the four levels will be based on symptom tolerance and successful completion of all exercises at the current level.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 18, 2018

Primary Completion (ACTUAL)

March 2, 2020

Study Completion (ACTUAL)

March 2, 2020

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (ACTUAL)

June 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO18020291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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