Stationary Bike Study

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.

Study Overview

• Status: Completed
• Conditions: Vertigo; Dizziness; Concussion
• Intervention / Treatment: Other: Vestibular Rehabilitation + Aerobic Exercise; Other: 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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vestibular Rehabilitation + Areobic Exercise	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.
Active Comparator: Vestibular Rehabilitation	Other: Vestibular Rehabilitation; The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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 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
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Teresa Denham, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2014
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Vestibular
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: 14-01231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No