Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
Study NCT ID:
NCT06722768
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-11-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Patients who were diagnosed as probable iNPH and underwent CSF tap test at Yongin Severance Hospital, Korea between June 2021 and October 2024 enrolled to our study. Patients were considered as probable iNPH when both satisfying clinical criteria and radiologic criteria All patients underwent a spinal CSF tap test draining 30mL of CSF. Surgical treatment was considered for patients who positively responded to CSF tap test. All patients gave their informed consent to participation in the study.
Gait and balance were assessed both in pre-24 hr of CSF tap test and post-24 hr of CSF tap test. Additional analyses were performed on patients who underwent surgery.
Timed-up-and go Test (TUGT) and 10-meter walk Test (10MWT) were done to evaluate the gait of patients. TUGT timed how long it took participant to stand up, go 3 meters, turn around, come back 3 meters, and sit down. 10MWT calculated walking speed by dividing 10 meters by the time taken to walk the distance. These two tests were recorded and stored as a video. The Balance was assessed through Berg Balance Score (BBS). BBS evaluated set of 14 balance related tasks and scores out of 56 points.
The spatiotemporal gait parameters and data stream of plantar pressure and acceleration were investigated during 10MWT. The patients wore commercial smart insoles with embedded four pressure sensors and three-axis accelerometers (GDCA-MD®,Gilon, Republic of Korea) during 10MWT. It measures real-time plantar pressure in four areas of the foot(toe, lateral midfoot, medial midfoot, and heel) and three-axis acceleration and displays them on a tablet with automatically calculated spatiotemporal gait parameters(step count, cadence, stride length, stride time, swing ratio).
Cognitive and Urinary symptoms were assessed at the baseline. Mini-Mental State Examination (MMSE) was done to measure neuropsychological status. Urinary symptom was graded based on the Overactive Bladder Symptom Score(OABSS) and International Prostate Symptom Score(IPSS).
Gait and balance were assessed both in pre-24 hr of CSF tap test and post-24 hr of CSF tap test. Additional analyses were performed on patients who underwent surgery.
Timed-up-and go Test (TUGT) and 10-meter walk Test (10MWT) were done to evaluate the gait of patients. TUGT timed how long it took participant to stand up, go 3 meters, turn around, come back 3 meters, and sit down. 10MWT calculated walking speed by dividing 10 meters by the time taken to walk the distance. These two tests were recorded and stored as a video. The Balance was assessed through Berg Balance Score (BBS). BBS evaluated set of 14 balance related tasks and scores out of 56 points.
The spatiotemporal gait parameters and data stream of plantar pressure and acceleration were investigated during 10MWT. The patients wore commercial smart insoles with embedded four pressure sensors and three-axis accelerometers (GDCA-MD®,Gilon, Republic of Korea) during 10MWT. It measures real-time plantar pressure in four areas of the foot(toe, lateral midfoot, medial midfoot, and heel) and three-axis acceleration and displays them on a tablet with automatically calculated spatiotemporal gait parameters(step count, cadence, stride length, stride time, swing ratio).
Cognitive and Urinary symptoms were assessed at the baseline. Mini-Mental State Examination (MMSE) was done to measure neuropsychological status. Urinary symptom was graded based on the Overactive Bladder Symptom Score(OABSS) and International Prostate Symptom Score(IPSS).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: