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Enrolling by Invitation

NCT Number: NCT07137403

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

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?

Enrolling by Invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University Hospital

Umeå, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 6 years

  2. 6 year incidence of Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus

    Time frame: 6 years

    Number of individuals that have developed a Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus since their last visit to us, in our previous study VESPR.

Secondary outcomes

  1. MRI Biomarkers for prediction of HLGD

    Time frame: 6 years

    MRI biomarkers commonly used in hydrocephalus diagnostics such as Evans Index, Callosal Angle and DESH will be evaluated for prediction of HLGD development. New biomarkers will also be investigated as potential new diagnostic tools.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten
  • The Swedish Brain Foundation (Hjärnfonden)

Registry information

Official study 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

Acronym: VESPR2

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 22, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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