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

Active, not recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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 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

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
Intervention / Treatment
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

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

Linkoeping University

Investigators

  • 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)

March 11, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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