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Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH

Recruitingn/aAges any - anyAllYonsei University
NCT06722768 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to to evaluate various gait parameters by a sensor-embedded smart insole before and after the cerebrospinal fluid (CSF) tap test in idiopathic normal pressure hydrocephalus (iNPH) patients. The main questions it aims to answer are: * Does the CSF tap test enhance gait and balance parameters in participants? * Does the CSF tap test enhance cognitive and urinary symptoms in participants? Researchers will compare pre- and post-CSF tap test gait and balance parameters by a sensor-embedded smart insole. Participants will: * Participate in physical function assessments including the 10-meter walk test, Timed Up and Go test, and Berg Balance Scale wearing sensor-embedded smart insoles before and after the CSF tap test. * Complete survey about cognitive and unary symptoms before and after the CSF tap test.

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📋 Eligibility rules (as published)
Inclusion Criteria: * individuals who have more than 1 symptom in the clinical triad including gradually developed gait disturbances mainly showing shuffling, magnetic, wide based gait * individuals who assessed a standardized cranial MRI scan and those with an Evans ratio greater than 0.30 were included in the study (Microvascular lesions in the white matter were accepted only if they were mild.) * individuals who voluntarily agree to participate in the study and sign a consent form Exclusion Criteria: * individuals with history of hemorrhage * individuals unable to walk independently on flat ground for 10 meters * individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems * individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings
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What it tests

  • Not listed
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Where

1 site
Yongin Severance Hospital
Yongin-si, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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