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Clinical Trials/NCT02945605
NCT02945605
Terminated
N/A

Effects of Early Vestibular Rehabilitation Compared to Standard Care in Patients With Dizziness and Balance Disorders After Sport and Recreation Concussion

University of Michigan1 site in 1 country1 target enrollmentMarch 9, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Concussion
Sponsor
University of Michigan
Enrollment
1
Locations
1
Primary Endpoint
Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2017
End Date
March 21, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bara Alsalaheen, PT, Ph.D.

Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Dizziness or balance problems within 10 days of concussion

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory

Time Frame: 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)

The change is calculated by subtracting the score obtained at a designated time point from the initial score.

Secondary Outcomes

  • Change in Dizziness Handicap Inventory (DHI)(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))
  • Change in Vestibular Ocular Motor Screening (VOMS)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Functional Gait Assessment (FGA)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Original and Cognitive Timed Up & Go (TUG)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Global Rating of Change (GRC)(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))
  • Time until medical clearance to return to sports/activities(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])
  • Change in Original and dual task Balance Error Scoring System (BESS)(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Limits of Stability (LOS) Test(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
  • Change in Clinical Dynamic Visual Acuity(Up to 5 weeks, or after full resolution of symptoms, whichever occurs first)

Study Sites (1)

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