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

NCT ID: NCT07137403

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-12-31

Brief Summary

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?

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Higher-level gait disorder

Individuals who in our previous study had a higher-level gait disorder

No interventions assigned to this group

Other gait disorder/No gait disorder

Individuals who did not have a higher-level gait disorder during their visit in our pervious study

No interventions assigned to this group

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Västerbotten

OTHER_GOV

Sponsor Role: collaborator

The Swedish Brain Foundation (Hjärnfonden)

UNKNOWN

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Jenny Ma Larsson

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny Larsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University Hospital

Umeå, , Sweden

Countries

Sweden

Other Identifiers

2025-02534-01

Identifier Type: -

Identifier Source: org_study_id