Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH

Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus

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.

Study Overview

• Status: Recruiting
• Conditions: Normal Pressure Hydrocephalus

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).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Na Young Kim, MD, PhD; Phone Number: +82 010 9127 4482; Email: kny8452@yuhs.ac
• Study Contact Backup: Name: Seung Ick Choi; Phone Number: +82 010 8821 5297; Email: rehab1@yuhs.ac

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
      • Recruiting
      • Yongin Severance Hospital
      • Contact: Na Young Kim, MD, PhD; Phone Number: +82 010 9127 4482; Email: kny8452@yuhs.ac
      • Contact: Seung Ick Choi; Phone Number: +82 010 8821 5297; Email: rehab1@yuhs.ac
      • Principal Investigator: Na Young Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Single general hospital

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
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.	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.
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.	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.
Cadence of walking	Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording steps per minute.	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.
Velocity of walking	Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording gait speed (km/h).	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.
Stride length of walking	Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording stride length (m).	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.
Stride time of walking	Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording stride time (s).	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.
Swing phase rate of walking	Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording swing phase rate (%).	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.
Mean peak pressure	The insole raw data stream was analyzed as following process. Pressure sensor measured foot pressure 40 times per second as relative values (0∼1,023). We obtained periodic foot pressure graphs for each foot region. From these graphs, mean peak pressure were determined by splitting the graph for each step, identifying the maximum pressure value in each step, and averaging the peak pressure values. The relative pressure values were subsequently converted into kilopascals using a validated algorithm with the conversion formula.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
Overactive Bladder Symptom Score	Questionnaire designed to assess the severity of overactive bladder symptoms and their impact on patients' quality of life.	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.
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.	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.

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Neurology. 2016 Feb 23;86(8):793. doi: 10.1212/WNL.0000000000002432.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: gait analysis; smart insole; Cerebrospinal fluid tap test
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: 9-2024-0130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No