Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795089
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Fredrik Lundin, Linkoeping University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Idiopathic Normal Pressure Hydrocephalus Procedure: Shunt surgery

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795089


Contacts
Layout table for location contacts
Contact: Johanna Rydja, PhD student +46725302010 johanna.rydja@regionostergotland.se
Contact: Fredrik Lundin, PhD +46101030000 fredrik.lundin@regionostergotland.se

Locations
Layout table for location information
Sweden
Neurology department, Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Johanna Rydja, PhD student    +46760302010    johanna.rydja@regionostergotland.se   
Contact: Fredrik Lundin, PhD    +46101030000    fredrik.lundin@regionostergotland.se   
Sponsors and Collaborators
Linkoeping University
Investigators
Layout table for investigator information
Study Director: Fredrik Lundin, PhD Neurology department, Linköping University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Fredrik Lundin, Principal Investigator, Linkoeping University
ClinicalTrials.gov Identifier: NCT04795089    
Other Study ID Numbers: 2020-00719
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fredrik Lundin, Linkoeping University:
gait analysis
outcome
surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases