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Effects of Early Vestibular Rehabilitation in Patients With Dizziness and Balance Disorders After Sport Concussion

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ClinicalTrials.gov Identifier: NCT02945605
Recruitment Status : Terminated (Because of recruitment challenges)
First Posted : October 26, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bara Alsalaheen, PT, Ph.D., University of Michigan

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.

Condition or disease Intervention/treatment Phase
Brain Concussion Other: Early Vestibular Rehabilitation Other: Standard of Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Early Vestibular Rehabilitation Compared to Standard Care in Patients With Dizziness and Balance Disorders After Sport and Recreation Concussion
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Vestibular Rehabilitation
Participants in this group will receive a customized vestibular rehabilitation program designed and implemented by a vestibular physical therapist. The vestibular physical therapy must be initiated within 72 hours after randomization. Participants in this group will continue to receive standard of care treatment as directed by their physician.
Other: Early Vestibular Rehabilitation

Two visits/week for a maximum of 5 weeks will be provided with the approximate duration for each visit estimated at 50-60 minutes. Consistent with a previously validated framework for exercise prescription in patients with concussion, the exercises provided by the treating therapist can be classified into five main exercise categories:

  1. Eye-Head coordination, gaze stability and convergence exercises
  2. Sitting balance
  3. Standing static balance (i.e. feet-in-place)
  4. Dynamic balance (feet moving, but not walking)
  5. Ambulation (gait exercises)
  6. Other exercises: Sport specific exercises, Canalith repositioning maneuvers are recorded as others

Other: Standard of Care
Standard care as directed by a physician.

Active Comparator: Standard of Care
Participants in this group will receive standard care as directed by their physician.
Other: Standard of Care
Standard care as directed by a physician.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Dizziness Handicap Inventory (DHI) [ 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 DHI assesses the individual's handicap due to their dizziness problem in 25 items relating to physical, emotional, and functional domains. The highest overall score of the test is 100 with higher scores indicating greater dizziness handicap. Participants who are 18 years or older on the initial assessment day will complete the original DHI, and participants younger than 18 will complete the adolescents version of DHI.

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


  2. Global Rating of Change (GRC) [ 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) ]
    GRC scales ask that a person assess his or her current health status, recall that status at a previous time-point, and then calculate the difference between the two. The scoring ranges from "A very great deal worse (-7)" to "A very great deal better (7)."

  3. Change in Vestibular Ocular Motor Screening (VOMS) [ Time Frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first ]

    Participants will complete the VOMS testing seven items: smooth pursuit, saccades (horizontal and vertical), vestibulo-ocular reflex (VOR) (horizontal and vertical), vision motion sensitivity testing, and Near-Point-of-Convergence (NPC) distance (three trials). Participants are asked to report the intensity, using a scale from 0 (none) -10 (severe), of four possible symptoms (headache, dizziness, nausea, and fogginess). The participant reports at baseline and after each of the seven VOMS tests. Any change in each of the four symptoms from baseline is reported for each of the seven VOMS items. The total symptom score is calculated by summating any change in four symptoms from baseline for each of the seven VOMS tests.

    The change is calculated by subtracting the score obtained at the termination of the study from the initial score.


  4. Change in Functional Gait Assessment (FGA) [ Time Frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first ]

    The FGA assesses the ability to walk with head turns, changes of speed, pivot turns, backwards and narrow base of support. The scale for each item ranges from 0-3, where 0 means severe impairment and 3 means normal. The highest possible score is 30. Higher scores indicate better performance.

    The change is calculated by subtracting the score obtained at the termination of the study from the initial score.


  5. Change in Original and Cognitive Timed Up & Go (TUG) [ Time Frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first ]

    The TUG is a timed test during which the participant stands from a chair, walks three meters at their normal walking speed, returns to the chair, and sits down. The cognitive TUG is completed while counting backwards in threes from a random start point. An automaticity index is calculated to assess the impact of both dual tasks. The speed under the dual-task condition is expressed as a percentage of the speed under the single-task condition: (single task/dual task) *100. A maximal achievable score of 100% indicated no decrease in performance under the dual-task condition. This index is developed as a method for standardizing the assessment of dual-task performance and its effect on automaticity.

    The change is calculated by subtracting the score obtained at the termination of the study from the initial score.


  6. Change in Clinical Dynamic Visual Acuity [ Time Frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first ]

    First perform the test for static visual acuity: patient may wear glasses or contacts. Have patient sit/stand about 10 feet away from eye chart (LogMAR). Have them read the lowest line they can see until they cannot correctly identify all the letters in a given line. Note which line this is. Dynamic Visual Acuity: Stand behind patient and tilt their head down 20°. Rotate their head at 2 Hz (240 beats/min on metronome) and have them read the lowest line possible until they cannot correctly identify all the letters in a given line. Note which line this is. Abnormal Test: greater than 2 line difference or if patient experiences dizziness which they rate on a 0 to 10 scale.

    The change is calculated by subtracting the score obtained at the termination of the study from the initial score.


  7. Change in Original and dual task Balance Error Scoring System (BESS) [ Time Frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first ]

    Participants will perform the BESS while on a NeuroCom® portable force plate system. Participants are asked to stand on the force plate and maintain balance with eyes closed and hands on their iliac crests under 6 different conditions (20 seconds each):

    1. firm surface, feet together
    2. firm surface, single leg stance
    3. firm surface, tandem stance
    4. foam surface, feet together
    5. foam surface, single leg stance
    6. foam surface, tandem stance

    This procedure allows for simultaneous computation of sway by the force plate and clinical assessment of balance errors as indicated by the BESS.

    For the dual task Balance Error Scoring System, the BESS will be completed as per BESS protocol with a cognitive task of serial threes. For the serial threes task, participants are given a random number between 80 and 100 and instructed to subtract by threes. When participants fail to perform a correct subtraction, it is considered an error.


  8. Change in Limits of Stability (LOS) Test [ Time Frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first ]

    The LOS quantifies the maximum distance the patient can intentionally displace their Center of Gravity (COG) in the four cardinal directions and the four diagonal directions, and maintain stability at those positions. Measured parameters are reaction time, COG movement velocity, directional control, end point excursion, and maximum excursion.

    The change is calculated by subtracting the score obtained at the termination of the study from the initial score.


  9. Time until medical clearance to return to sports/activities [ Time Frame: 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] ]
    The number of days between concussion and the day when a physician provided full clearance to return to sport/activities



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dizziness or balance problems within 10 days of concussion

Exclusion Criteria:


Information from the National Library of Medicine

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): NCT02945605


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Bara Alsalaheen, PT, PhD University of Michigan

Publications:

Responsible Party: Bara Alsalaheen, PT, Ph.D., Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02945605     History of Changes
Other Study ID Numbers: HUM00109407
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dizziness
Brain Concussion
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating