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

NCT06722768 | Recruiting

• 1 other identifier: 9-2024-0130
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Pressure Hydrocephalus

Keywords

gait analysis; smart insole; Cerebrospinal fluid tap test

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Korean Mini-Mental State Examination

  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

  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

  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.

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single general hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 16995, South Korea

RECRUITING

Related Publications (6)

• 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.

  PMID: 18713572 BACKGROUND

• 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.

  PMID: 22282714 BACKGROUND

• 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.

  PMID: 26644048 BACKGROUND

• 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.

  PMID: 37082443 BACKGROUND

• 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.

  PMID: 10964082 BACKGROUND

• 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.

  PMID: 38139603 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Na Young Kim, MD, PhD

CONTACT

+82 010 9127 4482; kny8452@yuhs.ac

Seung Ick Choi

CONTACT

+82 010 8821 5297; rehab1@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 9, 2024
• Study Start: June 1, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)