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

Yonsei University

Status: Enrolling

Conditions: Normal Pressure Hydrocephalus

Study type: Observational

Funder types: Other

Identifiers

NCT06722768

9-2024-0130

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Responder group

Description:

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

Description:

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.