Stationary Bike Study

NCT02640599 | Completed

• 1 other identifier: 14-01231
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertigo; Concussion; Dizziness

Keywords

Vestibular; Rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Vestibular Rehabilitation + Areobic Exercise

EXPERIMENTAL

Other: Vestibular Rehabilitation + Aerobic Exercise

Vestibular Rehabilitation

ACTIVE COMPARATOR

Other: Vestibular Rehabilitation

Interventions

Vestibular Rehabilitation + Aerobic Exercise OTHER

Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.

Vestibular Rehabilitation + Areobic Exercise

Vestibular Rehabilitation OTHER

The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.

Vestibular Rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Vertigo; Brain Concussion; Dizziness

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Sensation Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Teresa Denham

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 29, 2015
• Study Start: November 10, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)