Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
NCT ID: NCT06722768
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2021-06-01
2025-02-28
Brief Summary
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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
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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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Responder group
Patients with iNPH were divided into responder group and non-responder group after CSF tap test.
The responder group consists of patients who underwent the tap test and exhibited improvements in gait and balance, including increased gait speed as measured by the 10-Meter Walk Test (10MWT), reduced time on the Timed Up and Go Test (TUGT), and resolution of shuffling, magnetic, and wide-based gait patterns. Classification were done by a multidisciplinary team including physiatrist, neurologist, and neurosurgeon.
Surgical treatment was carefully considered for the responder group. Patients who declined surgery or were considered at high risk for surgical complications due to advanced age or comorbidities were excluded. Patients who were able to get an operation primarily underwent shunt surgery.
Additional gait and balance analyses were performed on patients who underwent surgery within 24 hours after their last operation.
No interventions assigned to this group
Non-Responder group
Patients with iNPH were divided into responder group and non-responder group after CSF tap test.
The non-responder group consists of patients who underwent the tap test but did not exhibit improvements in gait or balance. Classification were done by a multidisciplinary team including physiatrist, neurologist, and neurosurgeon.
Surgical treatment was not considered for the responder group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Na Young Kim, MD, PhD
Role: primary
Seung Ick Choi
Role: backup
References
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Shprecher D, Schwalb J, Kurlan R. Normal pressure hydrocephalus: diagnosis and treatment. Curr Neurol Neurosci Rep. 2008 Sep;8(5):371-6. doi: 10.1007/s11910-008-0058-2.
Kiefer M, Unterberg A. The differential diagnosis and treatment of normal-pressure hydrocephalus. Dtsch Arztebl Int. 2012 Jan;109(1-2):15-25; quiz 26. doi: 10.3238/arztebl.2012.0015. Epub 2012 Jan 9.
Halperin JJ, Kurlan R, Schwalb JM, Cusimano MD, Gronseth G, Gloss D. Practice 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. Neurology. 2015 Dec 8;85(23):2063-71. doi: 10.1212/WNL.0000000000002193.
Dias SF, Graf C, Jehli E, Oertel MF, Mahler J, Schmid Daners M, Stieglitz LH. Gait pattern analysis in the home environment as a key factor for the reliable assessment of shunt responsiveness in patients with idiopathic normal pressure hydrocephalus. Front Neurol. 2023 Apr 4;14:1126298. doi: 10.3389/fneur.2023.1126298. eCollection 2023.
Stolze H, Kuhtz-Buschbeck JP, Drucke H, Johnk K, Diercks C, Palmie S, Mehdorn HM, Illert M, Deuschl G. Gait analysis in idiopathic normal pressure hydrocephalus--which parameters respond to the CSF tap test? Clin Neurophysiol. 2000 Sep;111(9):1678-86. doi: 10.1016/s1388-2457(00)00362-x.
Jang CW, Park K, Paek MC, Jee S, Park JH. Validation of the Short Physical Performance Battery via Plantar Pressure Analysis Using Commercial Smart Insoles. Sensors (Basel). 2023 Dec 11;23(24):9757. doi: 10.3390/s23249757.
Other Identifiers
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9-2024-0130
Identifier Type: -
Identifier Source: org_study_id