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Smart insole to measure walking changes after spinal fluid tap in normal pressure hydrocephalus

Uses a sensor insole to track walking before and after a spinal fluid tap.

Key facts

Who runs it
Yonsei University
Where
South Korea1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH
Status
Recruiting
People taking part
50 people, planned
Started
1 Jun 2021
Planned end
Feb 2025
Type of study
Observational, 2 groups
Record updated
9 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with idiopathic normal pressure hydrocephalus (iNPH), a build-up of brain fluid that affects walking. Walking and balance are measured with a sensor insole before and after a spinal fluid tap test.

Sex
All sexes can join.
Disease stage
More than 1 symptom of the typical triad, including walking problems that came on slowly: shuffling, feet seeming stuck to the floor, or walking with feet wide apart. A brain MRI with an Evans ratio greater than 0.30. Small vessel changes in the brain's white matter are accepted only if mild.
Biomarker or test result
Brain MRI with an Evans ratio greater than 0.30.

Main reasons for not taking part

  • History of bleeding (hemorrhage)
  • Not able to walk 10 meters on flat ground without help
  • Serious heart, gut, lung or hormone (endocrine) disorders
  • Judged by the trial staff as not fit to take part because of important medical findings

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • individuals with history of hemorrhage
  • individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems
  • individuals unable to walk independently on flat ground for 10 meters
  • individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 2 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus
Plain-language title
Smart insole to measure walking changes after spinal fluid tap in normal pressure hydrocephalusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Publications
Record updated
9 December 2024