Actively Recruiting
Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
Led by Yonsei University · Updated on 2024-12-09
50
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have more than one symptom in the clinical triad including gradually developed gait disturbances such as shuffling, magnetic, or wide-based gait
- Have a standardized cranial MRI scan with an Evans ratio greater than 0.30
- Have only mild microvascular lesions in the white matter if present
- Voluntarily agree to participate and sign a consent form
You will not qualify if you...
- Have a history of hemorrhage
- Are unable to walk independently on flat ground for 10 meters
- Have clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems
- Are considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995
Actively Recruiting
Research Team
N
Na Young Kim, MD, PhD
CONTACT
S
Seung Ick Choi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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