Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
ConditionNormal Pressure Hydrocephalus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Single general hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: Responder group
Group B: Non-Responder group
Trial outcomes
Primary outcomes
1
Timed up and go test (TUG)
Researchers ask patients to rise from a seated position, walk a distance of 3 m, turn around, return to the chair, and sit back. The average time of three trials was recorded as a result.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.2
10 meter walk test (10MWT)
Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.3
Berg balance scale (BBS)
Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.4
Total steps of walking
Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording total steps.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.Secondary outcomes
1
Korean Mini-Mental State Examination
A test that assesses the degree of overall cognitive impairment, taking into account a person's level of education, and the test assesses time and place perception, attention and calculation, memory, language, and spatial and temporal organization. The examiner asks questions corresponding to the items on the test sheet below and record a score for the answers.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.2
Overactive Bladder Symptom Score
Questionnaire designed to assess the severity of overactive bladder symptoms and their impact on patients' quality of life.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.3
International Prostate Symptom Score
Questionnaire designed to evaluate the severity of lower urinary tract symptoms commonly associated with benign prostatic hyperplasia. It also assesses the impact of these symptoms on the patient's quality of life.
Time frame
This session will be performed at baseline and at end-point. A baseline assessment will be conducted within 24 hours before the CSF tap test, and an end-point assessment will be conducted within 24 hours after the CSF tap test.Sponsors and contacts
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Source ClinicalTrials.gov