Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Yongin Severance Hospital
RECRUITING
Yongin-si
Contact Information
Primary
Na Young Kim, MD, PhD
kny8452@yuhs.ac
+82 010 9127 4482
Backup
Seung Ick Choi
rehab1@yuhs.ac
+82 010 8821 5297
Time Frame
Start Date:2021-06-01
Estimated Completion Date:2025-02
Participants
Target number of participants:50
Treatments
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.