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NCT Number: NCT06722768

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

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.

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Key information

Conditions

Normal Pressure Hydrocephalus Brain Diseases Central Nervous System Diseases Hydrocephalus Hydrocephalus, Normal Pressure Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Timed up and go test (TUG)

    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.

    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.

  2. 10 meter walk test (10MWT)

    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.

    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.

  3. Berg balance scale (BBS)

    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.

    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.

  4. Total steps of walking

    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.

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording total steps.

  5. Cadence of walking

    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.

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording steps per minute.

  6. Velocity of walking

    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.

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording gait speed (km/h).

  7. Stride length of walking

    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.

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording stride length (m).

  8. Stride time of walking

    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.

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording stride time (s).

  9. Swing phase rate of walking

    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.

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole, recording swing phase rate (%).

  10. Mean peak pressure

    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.

    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.

Secondary outcomes

  1. Korean Mini-Mental State Examination

    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.

    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.

  2. Overactive Bladder Symptom Score

    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.

    Questionnaire designed to assess the severity of overactive bladder symptoms and their impact on patients' quality of life.

  3. International Prostate Symptom Score

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Na Young Kim, MD, PhD

CONTACT

[email protected]

+82 010 9127 4482

Seung Ick Choi

CONTACT

[email protected]

+82 010 8821 5297

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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