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Completed

NCT Number: NCT02640599

Stationary Bike Study

Investigators will use a stationary bike protocol to investigate whether patients with post concussion syndrome benefit from adding exertion training to a vestibular rehabilitation program.

Investigators examine the effect of aerobic exercise testing and training on individuals with concussion who are currently experiencing symptoms and examine the effect of aerobic exercise in combination with traditional vestibular rehabilitation.

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Key information

Conditions

Vertigo Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion Craniocerebral Trauma Dizziness Ear Diseases Head Injuries, Closed Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Trauma, Nervous System Vestibular Diseases Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

This is a randomized controlled single blind pilot study testing the hypothesis that the combination of aerobic exercise plus vestibular rehabilitation will result in greater reduction of symptoms of dizziness and imbalance compared to vestibular rehabilitation alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of concussion >14 days, <6 months
  • One or more of the following symptoms after most recent head injury: headache, dizziness, fatigue, irritability, insomnia, concentration or memory difficulty)
  • Age range - 18-70
  • Access to stationary bicycle
  • Ability to read and write sixth grade English

Exclusion criteria

  • Inability to participate in aerobic exercise for any reason
  • Pre-existing or current neurological or autonomic disease including persistent symptoms form previous concussion
  • Major depressive disorder
  • Litigation
  • Increased cardiac risk
  • Currently taking, Beta Blockers, or Anticonvulsants

Treatment and study plan

Vestibular Rehabilitation + Aerobic Exercise

Other

Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.

Vestibular Rehabilitation

Other

The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.

Primary outcomes

  1. Changes in Visual Analog Scale (VAS) of Dizziness Score

    Time frame: change in VAS of Dizziness Score from initial evaluation to week 6

  2. Changes in Dizziness Handicap Inventory (DHI) Score

    Time frame: change in DHI Score from initial evaluation to week 6

    25-item scale that addresses the functional, emotional, and physical components of dizziness. Higher scores indicate greater handicap (range, 0 - 100)

  3. Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool

    Time frame: change in symptoms from initial evaluation to week 6

  4. Changes in balance Error Scoring System (BESS) score

    Time frame: change in (BESS) Score from initial evaluation to week 6

    requires participants to maintain balance with eyes closed with their hands on their iliac crests under six different surface conditions. Number of errors in each trial are added together to obtain a total score (out of 60).

  5. Changes in Dynamic Visual Acuity (DVA) Score

    Time frame: change in DVA Score from initial evaluation to week 6

    instrumented, objective assessment of vestibulo-ocular reflex (VOR) function in response to head movement. The Dynamic Visual Acuity Test assesses visual acuity during head movement relative to baseline static visual acuity

  6. Changes in Sport Concussion Assessment Tool (SCAT-3) Score

    Time frame: change in (SCAT-3) from initial evaluation to week 6

    22 item postconcussion symptom scale using a seven point Likert rating. This scale provides an assessment of symptoms endorsed, along with a severity score. The maximum symptom score is 22, the symptom severity score is obtained by summing the rated symptom score for each symptom (maximum score 132).

  7. Functional Gait Assessment

    Time frame: change in gait from initial evaluation to week 6

    10-item test that measures gait with a narrow base of support, gait with eyes closed, ambulating backwards, as well as ambulation with head turns. The maximum score is 30. Higher scores indicate better performance.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2015
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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