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Stationary Bike Study

Primary Purpose

Vertigo, Concussion, Dizziness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Rehabilitation + Aerobic Exercise
Vestibular Rehabilitation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Vestibular, Rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vestibular Rehabilitation + Areobic Exercise

Vestibular Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Changes in Visual Analog Scale (VAS) of Dizziness Score
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)
Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool
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).
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
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).
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2015
Last Updated
January 6, 2020
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02640599
Brief Title
Stationary Bike Study
Official Title
The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Concussion, Dizziness
Keywords
Vestibular, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Rehabilitation + Areobic Exercise
Arm Type
Experimental
Arm Title
Vestibular Rehabilitation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Vestibular Rehabilitation + Aerobic Exercise
Intervention Description
Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.
Intervention Type
Other
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.
Primary Outcome Measure Information:
Title
Changes in Visual Analog Scale (VAS) of Dizziness Score
Time Frame
change in VAS of Dizziness Score from initial evaluation to week 6
Title
Changes in Dizziness Handicap Inventory (DHI) Score
Description
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
Title
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
Title
Changes in balance Error Scoring System (BESS) score
Description
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
Title
Changes in Dynamic Visual Acuity (DVA) Score
Description
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
Title
Changes in Sport Concussion Assessment Tool (SCAT-3) Score
Description
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
Title
Functional Gait Assessment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Denham
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Stationary Bike Study

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