VertigoNCT02640599
Stationary Bike Study
A study testing Vestibular Rehabilitation + Aerobic Exercise and Vestibular Rehabilitation in people with Vertigo and Concussion, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vertigo, Concussion, Dizziness
- What is being tested?
- Vestibular Rehabilitation + Aerobic Exercise and Vestibular Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2014to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion
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.
- Conditions
- Vertigo, Concussion, Dizziness
- Being tested
- Vestibular Rehabilitation + Aerobic Exercise, Vestibular Rehabilitation
- Keywords
- Vestibular, Rehabilitation
- Medical subject headings
- Vertigo, Brain Concussion, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation + Aerobic ExerciseOther
Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.
Vestibular RehabilitationOther
The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation + Areobic Exercise | Experimental | Not described Receives: Other: Vestibular Rehabilitation + Aerobic Exercise |
| Vestibular Rehabilitation | Active comparator | Not described Receives: Other: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual Analog Scale (VAS) of Dizziness Score
Measured: change in VAS of Dizziness Score from initial evaluation to week 6
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)
Measured: change in DHI Score from initial evaluation to week 6
Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool
Measured: change in symptoms from initial evaluation to week 6
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).
Measured: change in (BESS) Score from initial evaluation to week 6
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
Measured: change in DVA Score from initial evaluation to week 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).
Measured: change in (SCAT-3) from initial evaluation to week 6
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.
Measured: change in gait from initial evaluation to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start10 Nov 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Denham, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640599
- Sponsor's protocol ID
- 14-01231
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion
- ClinicalTrials.gov ID
- NCT02640599
- Acronym / sponsor ID
- 14-01231
- Conditions
- Vertigo, Concussion, Dizziness
- Keywords
- Vestibular, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation + Areobic Exercise | Experimental | Other: Vestibular Rehabilitation + Aerobic Exercise |
| Vestibular Rehabilitation | Active comparator | Other: Vestibular Rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation + Aerobic ExerciseSubjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program. | Other | Vestibular Rehabilitation + Areobic Exercise |
| Vestibular RehabilitationThe control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week. | Other | Vestibular Rehabilitation |
Primary outcome
Changes in Visual Analog Scale (VAS) of Dizziness Score
Time frame: change in VAS of Dizziness Score from initial evaluation to week 6
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)
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
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).
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
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Denham principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation + Aerobic Exercise and Vestibular Rehabilitation in people with Vertigo and Concussion, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visual Analog Scale (VAS) of Dizziness Score (time frame: change in VAS of Dizziness Score from initial evaluation to week 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.