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Vestibular Treatment in Adolescents Following Sport Related Concussion

Primary Purpose

Vestibular Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Exercise Intervention
Standard of Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder focused on measuring adolescent, concussion

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UMPC Sports Medicine Concussion Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard of Care Group

Vestibular Exercise Intervention Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2018
Last Updated
March 3, 2020
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03555370
Brief Title
Vestibular Treatment in Adolescents Following Sport Related Concussion
Official Title
RCT of Vestibular Treatment in Adolescents Following Sport Related Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder
Keywords
adolescent, concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Vestibular Exercise Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Exercise Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
The standard of care consists of standardized in office/at home behavioral management including sleep, hydration, nutrition, and stress management interventions.
Primary Outcome Measure Information:
Title
Change in VOMS Scores (Vestibular Ocular Motor Screening) from Baseline to 4 Week/Visit 2
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony P Kontos, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMPC Sports Medicine Concussion Research Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27325635
Citation
Bryan MA, Rowhani-Rahbar A, Comstock RD, Rivara F; Seattle Sports Concussion Research Collaborative. Sports- and Recreation-Related Concussions in US Youth. Pediatrics. 2016 Jul;138(1):e20154635. doi: 10.1542/peds.2015-4635. Epub 2016 Jun 20.
Results Reference
background
PubMed Identifier
25285866
Citation
O'Kane JW, Schiff MA. Concerns about concussion rates in female youth soccer-reply. JAMA Pediatr. 2014 Oct;168(10):968. doi: 10.1001/jamapediatrics.2014.780. No abstract available.
Results Reference
background
PubMed Identifier
27741219
Citation
Collins MW, Kontos AP, Okonkwo DO, Almquist J, Bailes J, Barisa M, Bazarian J, Bloom OJ, Brody DL, Cantu R, Cardenas J, Clugston J, Cohen R, Echemendia R, Elbin RJ, Ellenbogen R, Fonseca J, Gioia G, Guskiewicz K, Heyer R, Hotz G, Iverson GL, Jordan B, Manley G, Maroon J, McAllister T, McCrea M, Mucha A, Pieroth E, Podell K, Pombo M, Shetty T, Sills A, Solomon G, Thomas DG, Valovich McLeod TC, Yates T, Zafonte R. Statements of Agreement From the Targeted Evaluation and Active Management (TEAM) Approaches to Treating Concussion Meeting Held in Pittsburgh, October 15-16, 2015. Neurosurgery. 2016 Dec;79(6):912-929. doi: 10.1227/NEU.0000000000001447.
Results Reference
background
PubMed Identifier
25106780
Citation
Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.
Results Reference
background
PubMed Identifier
24337463
Citation
Collins MW, Kontos AP, Reynolds E, Murawski CD, Fu FH. A comprehensive, targeted approach to the clinical care of athletes following sport-related concussion. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):235-46. doi: 10.1007/s00167-013-2791-6. Epub 2013 Dec 12.
Results Reference
background
PubMed Identifier
34450120
Citation
Kontos AP, Eagle SR, Mucha A, Kochick V, Reichard J, Moldolvan C, Holland CL, Blaney NA, Collins MW. A Randomized Controlled Trial of Precision Vestibular Rehabilitation in Adolescents following Concussion: Preliminary Findings. J Pediatr. 2021 Dec;239:193-199. doi: 10.1016/j.jpeds.2021.08.032. Epub 2021 Aug 25.
Results Reference
derived

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Vestibular Treatment in Adolescents Following Sport Related Concussion

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