Vestibular Treatment in Adolescents Following Sport Related Concussion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03555370|
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Disorder||Behavioral: Vestibular Exercise Intervention Behavioral: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||RCT of Vestibular Treatment in Adolescents Following Sport Related Concussion|
|Estimated Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||June 15, 2019|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555370
|Contact: Anthony P Kontos, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|UMPC Sports Medicine Concussion Research Program|
|Pittsburgh, Pennsylvania, United States, 15203|
|Principal Investigator:||Anthony P Kontos, PhD||University of Pittsburgh|