Clinical trial NCT02640599: Stationary Bike Study
Official title: The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertigo
Concussion
Dizziness
Keywords: Vestibular
Rehabilitation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in Visual Analog Scale (VAS) of Dizziness Score
timeFrame: change in VAS of Dizziness Score from initial evaluation to week 6
measure: Changes in Dizziness Handicap Inventory (DHI) Score
timeFrame: change in DHI Score from initial evaluation to week 6
measure: Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool
timeFrame: change in symptoms from initial evaluation to week 6
measure: Changes in balance Error Scoring System (BESS) score
timeFrame: change in (BESS) Score from initial evaluation to week 6
measure: Changes in Dynamic Visual Acuity (DVA) Score
timeFrame: change in DVA Score from initial evaluation to week 6
measure: Changes in Sport Concussion Assessment Tool (SCAT-3) Score
timeFrame: change in (SCAT-3) from initial evaluation to week 6
measure: Functional Gait Assessment
timeFrame: change in gait from initial evaluation to week 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Teresa Denham
role: PRINCIPAL_INVESTIGATOR
References: