Stationary Bike Study

Dizziness Clinical Trial

Official title:

The Effect of Vestibular and Exertion Training on Gait, Balance and Dizziness in Individuals With Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640599
• Other study ID #: 14-01231
• Status: Completed
• Phase: N/A
• Start date: November 10, 2014
• Est. completion date: August 2018

Study information

• Verified date: January 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Concussion
• Dizziness
• Vertigo

Intervention

Other:
• Vestibular Rehabilitation + Aerobic Exercise
Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.
• Vestibular Rehabilitation
The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Visual Analog Scale (VAS) of Dizziness Score		change in VAS of Dizziness Score from initial evaluation to week 6
Primary	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 DHI Score from initial evaluation to week 6
Primary	Change in the number of symptoms on checklist of the Sports Concussion Assessment Tool		change in symptoms from initial evaluation to week 6
Primary	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).	change in (BESS) Score from initial evaluation to week 6
Primary	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	change in DVA Score from initial evaluation to week 6
Primary	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).	change in (SCAT-3) from initial evaluation to week 6
Primary	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.	change in gait from initial evaluation to week 6