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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042190060

Registered date:09/08/2019

Analyses of the equilibrium and cortical function after use of TPAD

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedchronic vertigo
Date of first enrollment05/09/2019
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)1. A study for healthy adults Task:A healthy subject will stand and balance on the rubber mat with closed eyes for 30sec and sit on the chair with open eyes for 60secs sequentially and repeat that task ten times with or without TPAD. 2. A study for the patient with chronic vertigo Task:A patient with chronic vertigo will perform the TPAD rehabilitation for 15 minutes twice in a day for three months.

Outcome(s)

Primary Outcome1 A study for healthy adults Data of stabilometry (outer peripheral area, locus length per unit area, Romberg ratio) 2 A study for the patient with chronic vertigo Value of dizziness handicap inventory at 12 weeks later from the onset of TPAD rehabilitation
Secondary OutcomeHemodynamic response recorded with Near-infrared spectroscopy(NIRS)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 75age old
GenderBoth
Include criteria1. A study for healthy adults A healthy adult 1) over 20 years old, 2) who have a sufficient ability to implement the operation smoothly 3) who provided the informed consent based on the free will 2. A study for the patient with chronic vertigo A patient of chronic vertigo 1)who have a vertiginous sensation or a disequilibrium continuing more than three months 2)who have a sufficient ability to implement the operation smoothly 3) who provided the informed consent based on the free will
Exclude criteria1. A study for healthy adults The person 1)who does not provide the informed consent, 2)who is over 75 year old , 3)who have had the operation of middle or inner ear, neurosurgical or orthopedic operation in the past 4) who have had psychiatric disorder in the past 5)who have the canal paralysis on caloric test or video head impulse test 6)who have taken the drug with inner ear toxicity, such as antituberculous agent, in a certain period 7) who have had some traumatic injury of head, four limbs or body in the past, 8)whom doctor judged not to be able to come to our hospital or to go back home safely after the test 9)who is or might be pregnant, or hope for the pregnancy during the study period, or does not use appropriate sterilization 10)whom the doctor judged to be in adequate as a subject 2. A study for the patient with chronic vertigo The patient 1) who does not provide the informed consent 2)who want to stop the treatment 3)who stopped the treatment by oneself 4)who cannot continue to write a diary of vertigo 5)who cannot continue to do TPAD rehabilitation 6)whom the doctor judged not to be able to come to our hospital or to go back home safely after the test 7)who is or might be pregnant, or hope for the pregnancy during the study period, or does not use appropriate sterilization 8)whom the doctor judged to be in adequate as a subject

Related Information

Contact

Public contact
Name Hiromasa Takakura
Address Sugitani2630, Toyama, Toyama, Japan Toyama Japan 930-0194
Telephone +81-76-434-7368
E-mail hiromasa@med.u-toyama.ac.jp
Affiliation Toyama University Hospital
Scientific contact
Name Hiromasa Takakura
Address Sugitani2630, Toyama, Toyama, Japan Toyama Japan 930-0194
Telephone +81-76-434-7368
E-mail hiromasa@med.u-toyama.ac.jp
Affiliation Toyama University Hospital