Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03555370
Other study ID # PRO18020291
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2018
Est. completion date March 2, 2020

Study information

Verified date March 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2, 2020
Est. primary completion date March 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States UMPC Sports Medicine Concussion Research Program Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (5)

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). pii: e20154635. doi: 10.1542/peds.2015-4635. Epub 2016 Jun 20. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04353115 - A Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Active, not recruiting NCT04479761 - Sensory Integration of Auditory and Visual Cues in Diverse Contexts N/A
Recruiting NCT03624283 - Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV N/A
Recruiting NCT03690817 - Hearing Loss, Vestibular Loss and Cognitive Performance
Not yet recruiting NCT05322538 - Menier's Disease - Bone Density Study N/A
Completed NCT05795530 - Vestibular Function in Cochlear Implants
Completed NCT03330262 - Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability N/A
Not yet recruiting NCT06177132 - Vestibular Infant Screening - Rehabilitation N/A
Completed NCT03952936 - Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study N/A
Recruiting NCT05436067 - Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements N/A
Completed NCT03951584 - Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Recruiting NCT06407726 - Comparative Effects of Virtual Reality and Vestibular Exercises on Balance Gait in Older Adults N/A
Active, not recruiting NCT05793216 - VestibulOTherapy: Vestibular Impact on Learning N/A
Recruiting NCT05741515 - Vestibular Balance Therapy Intervention for Children N/A
Recruiting NCT04851184 - Dose of Vestibular Rehabilitation for Vestibular Hypofunction N/A
Not yet recruiting NCT06300840 - Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH) N/A