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Enrolling by invitation NCT07137403

Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality

Observational Idiopathic Normal Pressure Hydrocephalus (INPH) Gait Disorders, Neurologic Gait Disorders in Old Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Idiopathic Normal Pressure Hydrocephalus (INPH), Gait Disorders, Neurologic, Gait Disorders in Old Age. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality - Damage to the Glymphatic System May be the Cause

Overview

We live in an aging population and a third of the older population has a gait disorder that may cause institutionalization, and increased mortality. Sixteen percent of them have a slow, unsteady, neurological gait disorder, called Higher-Level Gait Disorder (HLGD). A known cause of HLGD is Idiopathic Normal Pressure Hydrocephalus (INPH), which is a treatable neurological disease. More than half of individuals with HLGD meet the diagnostic criteria for INPH as they have wide brain ventricles on MRI images of the brain, but far from all of these are in contact with the healthcare system. Possibly, HLGD without wide brain ventricles and where no other known explanation for the symptom is found could be a variant of or a precursor to INPH. Gait disorder is common among older people and can lead to falls and reduced quality of life. Complications after falls contribute to both increased mortality and increased costs in society. Therefore, it is important to have a solid knowledge of different types of gait disorders and how they can be treated. Our research will contribute with information about how HLGD affects the individual and how affected individuals can be investigated and helped. The disease mechanisms behind INPH and often behind HLGD are unknown. It is also unknown how often older individuals are affected by HLGD and how high the mortality is for those affected. It is likely that the incidence of HLGD is high and that it is linked to an increased mortality. It is also likely that the disease mechanism behind the symptom is the same as that of INPH and that HLGD can be detected with the help of brain imaging. In this epidemiological cohort study, we want to answer the following overarching questions: What is the incidence and mortality of HLGD and INPH? Can HLGD be predicted using biomarkers and what disease mechanism causes HLGD?

Primary outcome measures

  • Mortality [Time frame: 6 years]
  • 6 year incidence of Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus [Time frame: 6 years]
Secondary outcome measures (1)
  • MRI Biomarkers for prediction of HLGD [Time frame: 6 years]

Eligibility criteria

Inclusion criteria

  • Participation in the study "Ventriculomegaly and gait disturbance in the senior population in the Region of Västerbotten" (VeSPR)

Exclusion criteria

  • Bedridden
  • Inability to leave informed consent due to cognitive decline

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Umeå University Hospital — Umeå

Identifiers

NCT: NCT07137403 · 2025-02534-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗