Evaluating gait changes in patients with normal pressure hydrocephalus using smart insoles
Official title: Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus
Run by Yonsei University · NCT06722768 · Data updated 2026-11-12
This study is testing if a CSF tap can improve walking and balance in people with normal pressure hydrocephalus by using smart insoles to track their movements.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin-si, Gyeonggi-do) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | February 2025 |
| Study ends | February 2025 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT06722768 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with probable iNPH who exhibit gait disturbances and meet specific clinical and radiologic criteria.
✕Probably not a fit
Patients with significant cardiovascular, gastrointestinal, respiratory, or endocrine disorders, or those unable to walk independently, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess gait and balance changes in patients diagnosed with idiopathic normal pressure hydrocephalus (iNPH) before and after a cerebrospinal fluid (CSF) tap test. Participants will wear sensor-embedded smart insoles during physical function assessments, including the 10-meter walk test and Timed Up and Go test, to gather data on their gait parameters. The study will also evaluate cognitive and urinary symptoms through surveys administered before and after the CSF tap test. The goal is to determine if the CSF tap test leads to improvements in these areas.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of the CSF tap test in improving gait and balance in iNPH patients.
How similar studies have gone: While there have been studies on gait analysis in neurological conditions, this specific approach using smart insoles in conjunction with a CSF tap test is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea Recruiting
Study contacts
- Study coordinator: Na Young Kim, MD, PhD
- Email: kny8452@yuhs.ac
- Phone: +82 010 9127 4482
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.