Normal pressure hydrocephalus: diagnosis and treatment.
David Shprecher, Jason Schwalb, Roger Kurlan
https://pubmed.ncbi.nlm.nih.gov/18713572Actively Recruiting
All Genders
ID06722768
Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus
Led by Yonsei University · Updated on 2024-12-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating gait and balance changes in patients with idiopathic normal pressure hydrocephalus (iNPH) using a sensor-embedded smart insole before and after a cerebrospinal fluid (CSF) tap test. The study aims to find out if the CSF tap test improves gait, balance, cognitive function, and urinary symptoms in these patients by comparing measurements taken before and after the test. Participants undergo assessments including the 10-meter walk test, Timed Up and Go test, and Berg Balance Scale while wearing the smart insoles that measure real-time plantar pressure and acceleration. Patients are classified into responder or non-responder groups based on improvements after the CSF tap test. Those who respond positively may be considered for shunt surgery, and additional gait and balance tests occur after surgery. During the study, participants complete physical function tests and surveys about cognitive and urinary symptoms both before and within 24 hours after the CSF tap test. The main measurements include walking speed, step count, cadence, stride characteristics, balance scores, and cognitive and urinary symptom scores. Data is collected via video recordings and sensor readings from the smart insoles to monitor changes associated with the CSF tap test.
CONDITIONS
Brief Title
Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals with more than one symptom in the clinical triad, including gradually developed gait disturbances such as shuffling, magnetic, or wide-based gait
- Individuals who had a standardized cranial MRI scan with an Evans ratio greater than 0.30 and only mild microvascular white matter lesions
- Individuals who voluntarily agree to participate in the study and sign a consent form
You will not qualify if you...
- Individuals with a 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 based on significant medical findings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 24 hours before and after the CSF tap test
Participants undergo a cerebrospinal fluid (CSF) tap test where 30mL of CSF is drained to assess gait and balance changes.
2 visits (in-person) within 48 hours
Long-term Monitoring
Duration - Up to 3 years until study completion
Participants are observed after the CSF tap test to monitor gait and balance changes and to decide on surgical treatment for responders.
Additional visits depending on clinical follow-up and treatment decisions
Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995
Actively Recruiting
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Research Team
N
Na Young Kim, MD, PhD
S
Seung Ick Choi
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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Published Research Related To This Trial
The differential diagnosis and treatment of normal-pressure hydrocephalus.
Michael Kiefer, Andreas Unterberg
https://pubmed.ncbi.nlm.nih.gov/22282714Practice guideline: Idiopathic normal pressure hydrocephalus: Response to shunting and predictors of response: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.
John J Halperin, Roger Kurlan, Jason M Schwalb...
https://pubmed.ncbi.nlm.nih.gov/26644048Gait pattern analysis in the home environment as a key factor for the reliable assessment of shunt responsiveness in patients with idiopathic normal pressure hydrocephalus.
Sandra Fernandes Dias, Christina Graf, Elisabeth Jehli...
https://pubmed.ncbi.nlm.nih.gov/37082443Gait analysis in idiopathic normal pressure hydrocephalus--which parameters respond to the CSF tap test?
H Stolze, J P Kuhtz-Buschbeck, H Drücke...
https://pubmed.ncbi.nlm.nih.gov/10964082Validation of the Short Physical Performance Battery via Plantar Pressure Analysis Using Commercial Smart Insoles.
Chan Woong Jang, Kyoungmin Park, Min-Chul Paek...
https://pubmed.ncbi.nlm.nih.gov/38139603