Back to resultsWalking Pattern Characteristics in Normal Pressure Hydrocephalus (NPH wearables)
Primary Purpose
Idiopathic Normal Pressure Hydrocephalus (INPH)
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Normal Pressure Hydrocephalus (INPH)
Eligibility 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:
- Informed Consent as documented by signature prior to any study related procedures or informed consent by a legal representative in case of cognitive deficits.
- Male and female patients alike
- Age between 60 and 100 years
- Clinical suspect for NPH
- Significant improvement (by more than 10%) in walking speed or endurance in a standardized CSF-TAP test (of at least 35 ml CSF).
- Planned implantation of a VP shunt for NPH treatment (independently from the study).
Matched controls group:
- Informed Consent as documented by signature prior to any study related procedures
- Male and female patients alike (matched to group 1)
- Age between 60 and 100 years (matched to group 1)
- No clinical suspect for NPH or any other movement disorder
Young controls group:
- Informed Consent as documented by signature prior to any study related procedures
- Male and female patients alike (matched to group 1)
- Age between 18 and 40 years
- No clinical suspect for NPH or any other movement disorder
Exclusion Criteria:
- Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
- Apparent or suspected movement disorder or other known disorder, which might affect normal standing or walking
- Cardiovascular disorders, which might affect physical resilience
- Pregnant women
- Pre-menopausal state of female patients and probands in groups 1 and 2.
- Children and adolescents
Sites / Locations
- Dept. of Neurosurgery, Zurich University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
iNPH patients
Healthy volunteers
Young healthy volunteers
Arm Description
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.
20 volunteers, matched with group 1 concerning sex and age.
20 volunteers, matched with group 1 concerning sex only and between 18 and 40 years old.
Outcomes
Primary Outcome Measures
Walking characteristics
Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)
Secondary Outcome Measures
4 minutes timed Walk test
Standard test (seconds)
180 degree turnaround test
Participants are asked to turn by 180 degrees. Steps needed are counted.
Kiefer score
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Kiefer score
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Stein and Langfitt score
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
Stein and Langfitt score
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
NPH recovery rate
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
Evan´s Index
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
Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign
Positivity of standard sign in preoperative CT or MRI imaging, hinting at presence of iNPH. Values: Positive/Negative
Time from appearance of first symptoms to surgery
From first appearance of symptoms to surgery in years
3-dimensional characterization of walking patterns
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
3-dimensional characterization of walking patterns
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Full Information
NCT ID
NCT04702035
First Posted
November 15, 2020
Last Updated
May 12, 2023
Sponsor
University of Zurich
Collaborators
ETH Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04702035
Brief Title
Walking Pattern Characteristics in Normal Pressure Hydrocephalus
Acronym
NPH wearables
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
ETH Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Normal Pressure Hydrocephalus (INPH)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iNPH patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
20 volunteers, matched with group 1 concerning sex and age.
Arm Title
Young healthy volunteers
Arm Type
Active Comparator
Arm Description
20 volunteers, matched with group 1 concerning sex only and between 18 and 40 years old.
Intervention Type
Device
Intervention Name(s)
Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking characteristics
Description
Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)
Time Frame
Between 2 weeks to 6 months after CSF diversion surgery
Secondary Outcome Measure Information:
Title
4 minutes timed Walk test
Description
Standard test (seconds)
Time Frame
immediately after fixation of IMUs
Title
180 degree turnaround test
Description
Participants are asked to turn by 180 degrees. Steps needed are counted.
Time Frame
immediately after fixation of IMUs
Title
Kiefer score
Description
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Time Frame
before surgery
Title
Kiefer score
Description
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Time Frame
after surgery (range 2 weeks to 6 months)
Title
Stein and Langfitt score
Description
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
Time Frame
before surgery
Title
Stein and Langfitt score
Description
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
Time Frame
after surgery (range 2 weeks to 6 months)
Title
NPH recovery rate
Description
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
Time Frame
after surgery (range 2 weeks to 6 months)
Title
Evan´s Index
Description
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
Time Frame
before surgery
Title
Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign
Description
Positivity of standard sign in preoperative CT or MRI imaging, hinting at presence of iNPH. Values: Positive/Negative
Time Frame
before surgery
Title
Time from appearance of first symptoms to surgery
Description
From first appearance of symptoms to surgery in years
Time Frame
before surgery
Title
3-dimensional characterization of walking patterns
Description
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Time Frame
before surgery
Title
3-dimensional characterization of walking patterns
Description
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Time Frame
after surgery (range 2 weeks to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Informed Consent as documented by signature prior to any study related procedures or informed consent by a legal representative in case of cognitive deficits.
Male and female patients alike
Age between 60 and 100 years
Clinical suspect for NPH
Significant improvement (by more than 10%) in walking speed or endurance in a standardized CSF-TAP test (of at least 35 ml CSF).
Planned implantation of a VP shunt for NPH treatment (independently from the study).
Matched controls group:
Informed Consent as documented by signature prior to any study related procedures
Male and female patients alike (matched to group 1)
Age between 60 and 100 years (matched to group 1)
No clinical suspect for NPH or any other movement disorder
Young controls group:
Informed Consent as documented by signature prior to any study related procedures
Male and female patients alike (matched to group 1)
Age between 18 and 40 years
No clinical suspect for NPH or any other movement disorder
Exclusion Criteria:
Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
Apparent or suspected movement disorder or other known disorder, which might affect normal standing or walking
Cardiovascular disorders, which might affect physical resilience
Pregnant women
Pre-menopausal state of female patients and probands in groups 1 and 2.
Children and adolescents
Facility Information:
Facility Name
Dept. of Neurosurgery, Zurich University Hospital
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Sharing of data with other researchers is not intended.
Citations:
PubMed Identifier
32153420
Citation
Renggli D, Graf C, Tachatos N, Singh N, Meboldt M, Taylor WR, Stieglitz L, Schmid Daners M. Wearable Inertial Measurement Units for Assessing Gait in Real-World Environments. Front Physiol. 2020 Feb 20;11:90. doi: 10.3389/fphys.2020.00090. eCollection 2020.
Results Reference
background
Learn more about this trial
Walking Pattern Characteristics in Normal Pressure Hydrocephalus
We'll reach out to this number within 24 hrs