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Search / Trial NCT06722768

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

Launched by YONSEI UNIVERSITY · Dec 3, 2024

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Gait Analysis Smart Insole Cerebrospinal Fluid Tap Test

ClinConnect Summary

This clinical trial is looking at how a special test called a cerebrospinal fluid (CSF) tap affects walking and balance in people with a condition known as idiopathic normal pressure hydrocephalus (iNPH). Researchers want to find out if this test can improve not only how well participants walk but also their thinking abilities and urinary symptoms. They will use smart insoles that can measure different aspects of walking before and after the CSF tap test to see if there are any changes.

To be eligible for this study, participants need to have more than one symptom related to walking difficulties, such as a shuffling gait, and must have had a recent MRI scan that shows specific signs related to iNPH. Participants will undergo physical tests while wearing these smart insoles and will fill out surveys about their thinking and urinary symptoms. This study is currently recruiting participants of all genders, so if you or a loved one are interested, you can reach out to learn more about joining.

Gender

ALL

Eligibility criteria

  • 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

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Yongin Si, Gyeonggi Do, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported