Stationary Bike Study

Not Applicable

Completed

• Conditions: Concussion; Vertigo; Dizziness
• Interventions: Other: Vestibular Rehabilitation; Other: Vestibular Rehabilitation + Aerobic Exercise

• Registration Number: NCT02640599
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11-10
• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular Rehabilitation	Vestibular Rehabilitation	-
Vestibular Rehabilitation + Areobic Exercise	Vestibular Rehabilitation + Aerobic Exercise	-

Primary Outcome Measures

Name	Time	Method
Functional Gait Assessment	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.
Changes in Visual Analog Scale (VAS) of Dizziness Score	change in VAS of Dizziness Score from initial evaluation to week 6
Changes in Dizziness Handicap Inventory (DHI) Score	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)
Changes in balance Error Scoring System (BESS) score	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).
Changes in Sport Concussion Assessment Tool (SCAT-3) Score	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).
Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool	change in symptoms from initial evaluation to week 6
Changes in Dynamic Visual Acuity (DVA) Score	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States