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Stationary Bike Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02640599
Enrollment
27
Registered
2015-12-29
Start date
2014-11-10
Completion date
2018-08-31
Last updated
2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Dizziness, Vertigo

Keywords

Vestibular, Rehabilitation

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.

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Visual Analog Scale (VAS) of Dizziness Scorechange in VAS of Dizziness Score from initial evaluation to week 6
Changes in Dizziness Handicap Inventory (DHI) Scorechange in DHI Score from initial evaluation to week 625-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 Toolchange in symptoms from initial evaluation to week 6
Changes in balance Error Scoring System (BESS) scorechange in (BESS) Score from initial evaluation to week 6requires 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) Scorechange in DVA Score from initial evaluation to week 6instrumented, 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) Scorechange in (SCAT-3) from initial evaluation to week 622 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 Assessmentchange in gait from initial evaluation to week 610-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026