Ventriculomegaly and Gait Disturbance in the Senior Population in the Region of Västerbotten (VESPR)

January 10, 2022 updated by: Jan Malm, Umeå University

Gait and Balance Impairment, Dementia and Wide Brain Ventricles in the Ages 65-84 Years

Idiopathic normal pressure hydrocephalus (INPH) is a treatable disease of the elderly, typically causing gait impariment, dementia and urinary incontinence. The objective of this study is to make an epidemiological survey of INPH in Umeå, Sweden. Subjects with self-perceived gait impairments will be identified through a questionnaire. They will go through clinical examinations and have an MRI of the brain. A control population will also be investigated to enable comparisons between the populations. The main hypothesis is that the prevalence of INPH in the population is higher than what is previoulsy known.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

6500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 90737
        • Norrlands Universitetssjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 84 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The number of people, aged 65-84 years and living in Umeå, is approximately 18 000. Of these, 6500 will be randomly selected from the Swedish population registry. They will be asked to answer a mailed-out questionnaire regarding self-perceived gait impairment. Those with self-percieved gait impairment will be invited for clinical examinations as cases and a random selection of those without self-percieved gait impairment will be invited to participate in clinical examinations as controls.

Description

Inclusion Criteria:

- Living in Umeå, Sweden.

Exclusion Criteria:

  • Age <65 or >84 years when the questionnaire was sent out.
  • Death at the time for the clinical evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case
Subjects with subjective gait impariment according to questionnaire answers.
Control
Subjects without subjective gait impariment according to questionnaire answers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Idiopathic Normal Pressure Hydrocephalus
Time Frame: Through study completion, an average of approximately 1 month.
Diagnosis of INPH based on clinical evaluation and MRI.
Through study completion, an average of approximately 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Region Västerbotten

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

December 22, 2021

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/335-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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