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Walking Pattern Characteristics in Normal Pressure Hydrocephalus (NPH wearables)

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ClinicalTrials.gov Identifier: NCT04702035
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
ETH Zurich
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
20 patients who are diagnosed with NPH receive a set of 5 wearable gyroscopes (IMUs, ZurichMove sensors) for a period of 3 days for measurement and characterization of their walking in an ambulatory setting. At a follow-up 2 weeks to 6 months after CSF diversion surgery, the examination is repeated and improvement is measured. The data will be compared with a healthy group of 20 age- and gender-matched individuals as well a a group of 20 young individuals.

Condition or disease Intervention/treatment Phase
Idiopathic Normal Pressure Hydrocephalus (INPH) Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) Not Applicable

Detailed Description:

Temporary attachment of IMUs to wrists and ankles of the patients and probands for a period of three days and recording of movement during a 10 meter-walking test, 180° turnaround and during normal movement at home.

Group 1 (patients):

Patients with a completed diagnostic concerning iNPH, who are planned to receive a VP-shunt by their responsible neurosurgeon (independently from the study), will be included.

Before the shunt implantation, the patients will be examined at the USZ using wearable gyroscopes (like wristwatches) at both wrists and ankles as well as one around the body center.

The short examination will comprise a patient history (MoCa test, Kiefer-score, Stein- and Langfitt-Score), a short examination (4 minute walking test, 180° turnaround) in hospital. Afterwards, the patient goes home, where the gyroscopes examine walking patterns for a period of three days. After this period, the patient brings the devices back to the hospital. The surgery will take place afterwards, independently from the study, as well as adjustments of the shunt's flow-resistance for achievement of optimal response to the therapy. After this optimal result is achieved, but latest after 6 months, the examination will be repeated.

Groups 2 and 3 (controls):

As well 20 subjects matched for sex and age with the patient's group as 20 healthy young subjects will be examined just like the patients preoperatively. Walking patterns shall be compared to identify changes between pre- and postoperatively as well as differences between patients and controls.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three groups of individuals are enrolled in parralel: 20 iNPH patients, 20 age- and gender-matched healthy individuals and 20 young individuals.
Masking: None (Open Label)
Masking Description: unmasked
Primary Purpose: Diagnostic
Official Title: Walking Pattern Characteristics in Normal Pressure Hydrocephalus. A Phase I/II Open-label Single Center Trial to Characterize Disease-specific Walking Patterns Using Wearable Gyroscopes
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arms and Interventions
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Arm Intervention/treatment
Experimental: iNPH patients
20 patients with completed diagnostics concerning NPH, in which the indication for implantation of a VP shunt for NPH treatment was found by the responsible surgeon independently from the study.
 Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
All participants receive a set of 5 wearable IMUs for a period of 3 days. The IMUs are fixed at both wrists, ankles and one over the sternum. A 10-meter walking test, 180 degree turnaround test and normal walking at home are performed. Afterwards, the IMUs are removed for data extraction and evaluation. The patient group is examined a second time after CSF diversion surgery.
Active Comparator: Healthy volunteers
20 volunteers, matched with group 1 concerning sex and age.
 Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
All participants receive a set of 5 wearable IMUs for a period of 3 days. The IMUs are fixed at both wrists, ankles and one over the sternum. A 10-meter walking test, 180 degree turnaround test and normal walking at home are performed. Afterwards, the IMUs are removed for data extraction and evaluation. The patient group is examined a second time after CSF diversion surgery.
Active Comparator: Young healthy volunteers
20 volunteers, matched with group 1 concerning sex only and between 18 and 40 years old.
 Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
All participants receive a set of 5 wearable IMUs for a period of 3 days. The IMUs are fixed at both wrists, ankles and one over the sternum. A 10-meter walking test, 180 degree turnaround test and normal walking at home are performed. Afterwards, the IMUs are removed for data extraction and evaluation. The patient group is examined a second time after CSF diversion surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Walking characteristics [ Time Frame: Between 2 weeks to 6 months after CSF diversion surgery ]
    Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)


Secondary Outcome Measures :
  1. 4 minutes timed Walk test [ Time Frame: immediately after fixation of IMUs ]
    Standard test (seconds)

  2. 180 degree turnaround test [ Time Frame: immediately after fixation of IMUs ]
    Participants are asked to turn by 180 degrees. Steps needed are counted.

  3. Kiefer score [ Time Frame: before surgery ]
    Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity

  4. Kiefer score [ Time Frame: after surgery (range 2 weeks to 6 months) ]
    Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity

  5. Stein and Langfitt score [ Time Frame: before surgery ]
    Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency

  6. Stein and Langfitt score [ Time Frame: after surgery (range 2 weeks to 6 months) ]
    Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency

  7. NPH recovery rate [ Time Frame: after surgery (range 2 weeks to 6 months) ]
    Standard rate for success of CSF diversion treatment in NPH. Calculated as follows: (Kiefer score preoperatively - Kiefer score postoperatively) / Kiefer score preoperatively x 10; range 0-10; Higher indicates better response to surgery

  8. Evan´s Index [ Time Frame: before surgery ]
    Standard descriptor for width of lateral ventricles in iNPH. Calculated as maximum with of frontal horns / maximal diameter of brain in axial CT or MRI at the level of cella media; range: 0-1; higher indicates larger ventricles and more severe hydrocephlaus

  9. Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign [ Time Frame: before surgery ]
    Positivity of standard sign in preoperative CT or MRI imaging, hinting at presence of iNPH. Values: Positive/Negative

  10. Time from appearance of first symptoms to surgery [ Time Frame: before surgery ]
    From first appearance of symptoms to surgery in years

  11. 3-dimensional characterization of walking patterns [ Time Frame: before surgery ]
    Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.

  12. 3-dimensional characterization of walking patterns [ Time Frame: after surgery (range 2 weeks to 6 months) ]
    Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Age limits for the NPH patient group and the matched healthy vonunteers group are 60-100 years.

Age limits for the young healthy volunteers group are 18-40 years.

Inclusion Criteria:

NPH patient group:

  1. Informed Consent as documented by signature prior to any study related procedures or informed consent by a legal representative in case of cognitive deficits.
  2. Male and female patients alike
  3. Age between 60 and 100 years
  4. Clinical suspect for NPH
  5. Significant improvement (by more than 10%) in walking speed or endurance in a standardized CSF-TAP test (of at least 35 ml CSF).
  6. Planned implantation of a VP shunt for NPH treatment (independently from the study).

Matched controls group:

  1. Informed Consent as documented by signature prior to any study related procedures
  2. Male and female patients alike (matched to group 1)
  3. Age between 60 and 100 years (matched to group 1)
  4. No clinical suspect for NPH or any other movement disorder

Young controls group:

  1. Informed Consent as documented by signature prior to any study related procedures
  2. Male and female patients alike (matched to group 1)
  3. Age between 18 and 40 years
  4. No clinical suspect for NPH or any other movement disorder

Exclusion Criteria:

  1. Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
  2. Apparent or suspected movement disorder or other known disorder, which might affect normal standing or walking
  3. Cardiovascular disorders, which might affect physical resilience
  4. Pregnant women
  5. Pre-menopausal state of female patients and probands in groups 1 and 2.
  6. Children and adolescents
Contacts and Locations
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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): NCT04702035


Contacts
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Contact: Lennart H Stieglitz, MD +41442559905 lennart.stieglitz@usz.ch
Contact: Weber Doris +41442559905 doris.weber@usz.ch

Locations
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Switzerland
Dept. of Neurosurgery, Zurich University Hospital Recruiting
Zurich, Switzerland, 8091
Contact: Lennart H Stieglitz, MD    +41 44 255 9905    Lennart.Stieglitz@usz.ch   
Contact: Doris Weber    +41 44 255 9905    Doris.Weber@usz.ch   
Sponsors and Collaborators
University of Zurich
ETH Zurich
More Information
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Publications:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04702035    
Other Study ID Numbers: NPH wearables
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing of data with other researchers is not intended.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases