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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Timed up and go test (TUG) — 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.
• 10 meter walk test (10MWT) — 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.
• Berg balance scale (BBS) — 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.
• Total steps of walking — 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.
• Cadence of walking — 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.
• Velocity of walking — 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).
• Stride length of walking — 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).
• Stride time of walking — 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).
• Swing phase rate of walking — 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 (%).
• Mean peak pressure — 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.

Trial sites (1)

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