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CompletedNCT02640599Updated Jan 9, 2020

Stationary Bike Study

An interventional study of Vestibular Rehabilitation + Aerobic Exercise and Vestibular Rehabilitation in Vertigo, Concussion and Dizziness, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2014, registered Dec 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vertigo
  • Concussion
  • Dizziness

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Keywords

  • Vestibular
  • Rehabilitation
03

In context

Vertigo

248 studies on the registry are indexed under Vertigo; 39 are open to participants now.

This study's enrollment of 27 is below the median of 57 across 186 interventional studies indexed under Vertigo.

Browse Vertigo studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Vestibular Rehabilitation + Areobic Exercise

    Other: Vestibular Rehabilitation + Aerobic Exercise

  • Active comparator
    Vestibular Rehabilitation

    Other: Vestibular Rehabilitation

Interventions

  • OtherVestibular Rehabilitation + Aerobic Exercise

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

  • OtherVestibular Rehabilitation

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

06

What researchers measure

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

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

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

  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

    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).

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

  5. Changes in Dynamic Visual Acuity (DVA) Score

    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

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

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

    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).

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

  7. Functional Gait Assessment

    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.

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

07

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02640599
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Dec 29, 2015
Start date
Nov 10, 2014
Primary completion
Aug 2018
Completion
Aug 2018
Last update
Jan 9, 2020

Study contacts

Teresa Denham
principal investigator · New York University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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