An interventional study of Control and Vestibular Rehabilitation in Vestibular Migraine, Vestibular Disorder and Migraine Variant, sponsored by Ege University. Completed. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
Abstract: Introduction:
Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache.
Material and methods:
77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's enrollment of 77 is above the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →Ege University is the lead sponsor of 376 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Adaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day. Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around. Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides. The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit.
Behavioral: Vestibular Rehabilitation
Same exercises that were applied in first group were also applied to this group. For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.
Other: Control · Behavioral: Vestibular Rehabilitation
Patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.
Other: Control
Routine treatment
Exercise and rehabilitation programme was individualized
Dizziness Handicap Inventory
A standardized inventory to assess the impact of dizziness in patients' life.
Time frame: 6 months
Activities-specific balance confidence scale
A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.
Time frame: 6 months
Static Posturography
Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)
Time frame: 6 months
Vertigo attack severity
Self reported outcome in which patients give insight about their vertigo attack severity
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Apr 2016, 15 months.
Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 15 months is close to that.
Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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