Gait Pattern and Experienced Global Change After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus

March 10, 2023 updated by: Fredrik Lundin, Linkoeping University

Gait Pattern, Experienced Global Change, Sense of Coherence, Quality of Life, Anxiety and Depression Symptoms After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus, in Relation With Healthy Individuals

Part 1 Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable disabilities regarding gait, balance, cognition and continence. Analysis of the gait pattern in iNPH has an important part in clinical diagnosing and evaluation of outcome after shunt surgery. The gait pattern is only partly explained and more detailed information about gait in iNPH is needed in relation with ordinary clinical measurements.

Part 2 Approximately 70 % of patients with iNPH improve after shunt surgery. Commonly different grading scales and measurements regarding functions are used in the evaluation. To some extent, patients improve in Quality of life after surgery (QoL). In this study, the patient´s own grading of improvements in relation with QoL, sense of coherence (SOC) and symptoms of depression and anxiety are analyzed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Consecutive patients with iNPH, which are planed for shunt surgery at the neurological and neurosurgical departments of University Hospital of Linköping, are included. Before operation and 3 months postoperatively, the patient´s gait pattern are analyzed with RehaGait analysis system. The patients also fill in a questionnaire about SOC, QoL and symptoms of depression and anxiety at these assessment sessions. Additionally at the follow up, the patients are grading their overall experienced change and specified changes in gait, balance, continence and neuropsychology with the global Rating of Change Scale (GRC-scale). At baseline and at follow up, the patients also perform the ordinary clinical assessments with measurements covering the domains gait, balance, continence and neuropsychology in the iNPH-scale. A convenience sample of Healthy individuals aged > 60 years, conduct the same questionnaires: SOC, QoL and symptoms of depression and anxiety and perform the RehaGait analysis system once.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Linköping, Sweden
        • Neurology department, Linköping University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients: Al consecutively available patients evaluated for iNPH at Neurology department Linköping University hospital.

HI: Convenience sample among relatives, friends and using advertising.

Description

Inclusion criteria for patients:

  • iNPH-diagnosis according to the international guidelines (2005)
  • Planed for shunt surgery

Exclusion criteria for patients:

  • Cognitive impairment that makes it impossible to participate
  • Not able to walk 20 meters without walking aids (part 1)

Inclusion criteria for healthy individuals:

  • > 60 years of age
  • Subjectively healthy without any serious disease

Exclusion criteria healthy individuals:

  • Visible gait- or balance disturbance
  • Dementia diagnosis

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients
Patients with iNPH and shunt surgery.
Procedure: Shunt surgery
Patients are evaluated before and after shunt surgery which is a standard intervention in the clinical practice. HI do not undergo intervention.
Healthy individuals
Healthy controls with similar gender and age distribution as the patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed steps (number).
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Analyzed distance (m)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride duration (seconds)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Stride length (cm)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Cadence (steps per minute)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Gait phases (seconds)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Heel strike and Toe of angle (angle degree)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Circumduction (cm)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Ankle joint angle (degree of angle)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable: Knee joint angle (degree of angle)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Gait pattern assessed with the Hasomed RehaGait analyzer pro. Variable:Hip joint angle (degree of angle)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Mobile gait analysis system.
Change from baseline to 3 month follow-up for patients. Once for HI.
Grading of severity in idiopathic normal pressure hydrocephalus assessed with the Idiopathic Normal Pressure Hydrocephalus Scale
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1 and part 2. Scores 0-100, higher scores mean a better outcome.
Change from baseline to 3 month follow-up for patients. Once for HI.
Mobility, walking ability and balance assessed with the Timed up and Go test
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 1. Variables: Time in seconds and number of steps.
Change from baseline to 3 month follow-up for patients. Once for HI.
Rating of global change assessed with the Global Rating of Change Scale
Time Frame: Rating at 3 month follow-up for patients.
Measurement in part 2. Scores -5-5 in global change, gait, balance, continence and cognition. Higher scores mean a better outcome.
Rating at 3 month follow-up for patients.
Sense of Coherence assessed with the 29 item Orientation to life questionnaire - swedish version (KASAM questionnaire)
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Scores 29-203, higher scores mean a better outcome.
Change from baseline to 3 month follow-up for patients. Once for HI.
Anxiety and depression assessed with the Hospital Anxiety and Depression Scale
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Anxiety scores 0-21, Depression scores 0-21, lower scores mean a better outcome.
Change from baseline to 3 month follow-up for patients. Once for HI.
Health-related quality of life assessed with EQ-5D-5L
Time Frame: Change from baseline to 3 month follow-up for patients. Once for HI.
Measurement in part 2. Scores 5-25, higher scores mean a better outcome.
Change from baseline to 3 month follow-up for patients. Once for HI.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fredrik Lundin, PhD, Neurology department, Linköping University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-00719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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