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

MI-összefoglaló

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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.

Nem

All sexes can join.

A betegség stádiuma

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 vagy leletérték

Brain MRI with an Evans ratio greater than 0.30.

A részvétel fő kizáró okai

• 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

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• 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.