Clinical trial NCT02945605: Effects of Early Vestibular Rehabilitation in Patients With Dizziness and Balance Disorders After Sport Concussion
Official title: Effects of Early Vestibular Rehabilitation Compared to Standard Care in Patients With Dizziness and Balance Disorders After Sport and Recreation Concussion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Concussion
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 1
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.

Detailed description: As awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. Concussions can lead to a variety of symptoms that may last from days to weeks after injury.\[1\] Dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.\[2,3\] Additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.\[4\] Although there are few studies suggesting that vestibular rehabilitation after concussion is promising,\[5,6\] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. Due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. The purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to STANDARD care. The findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.

Eligibility criteria: Inclusion Criteria:

* Dizziness or balance problems within 10 days of concussion

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory
timeFrame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
Secondary outcomes:
measure: Change in Dizziness Handicap Inventory (DHI)
timeFrame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
measure: Global Rating of Change (GRC)
timeFrame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
measure: Change in Vestibular Ocular Motor Screening (VOMS)
timeFrame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
measure: Change in Functional Gait Assessment (FGA)
timeFrame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
measure: Change in Original and Cognitive Timed Up & Go (TUG)
timeFrame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
measure: Change in Clinical Dynamic Visual Acuity
timeFrame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
measure: Change in Original and dual task Balance Error Scoring System (BESS)
timeFrame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
measure: Change in Limits of Stability (LOS) Test
timeFrame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
measure: Time until medical clearance to return to sports/activities
timeFrame: The number of days between concussion and the day when a physician provided full clearance to return to sport/activities (retrieved from medical record) up to 52 weeks from concussion date. [the date of clearance - the concussion date]
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Bara Alsalaheen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7.
citation: Zhou G, Brodsky JR. Objective vestibular testing of children with dizziness and balance complaints following sports-related concussions. Otolaryngol Head Neck Surg. 2015 Jun;152(6):1133-9. doi: 10.1177/0194599815576720. Epub 2015 Mar 27.
citation: Corwin DJ, Wiebe DJ, Zonfrillo MR, Grady MF, Robinson RL, Goodman AM, Master CL. Vestibular Deficits following Youth Concussion. J Pediatr. 2015 May;166(5):1221-5. doi: 10.1016/j.jpeds.2015.01.039. Epub 2015 Mar 5.
citation: Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
citation: Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
citation: Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.