Walking Pattern Characteristics in Normal Pressure Hydrocephalus (NPH wearables)

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
• Intervention / Treatment: Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Dept. of Neurosurgery, Zurich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking characteristics	Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)	Between 2 weeks to 6 months after CSF diversion surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4 minutes timed Walk test	Standard test (seconds)	immediately after fixation of IMUs
180 degree turnaround test	Participants are asked to turn by 180 degrees. Steps needed are counted.	immediately after fixation of IMUs
Kiefer score	Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity	before surgery
Kiefer score	Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity	after surgery (range 2 weeks to 6 months)
Stein and Langfitt score	Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency	before surgery
Stein and Langfitt score	Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency	after surgery (range 2 weeks to 6 months)
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	after surgery (range 2 weeks to 6 months)
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	before surgery
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	before surgery
Time from appearance of first symptoms to surgery	From first appearance of symptoms to surgery in years	before surgery
3-dimensional characterization of walking patterns	Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.	before surgery
3-dimensional characterization of walking patterns	Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.	after surgery (range 2 weeks to 6 months)

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: ETH Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: NPH wearables

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of data with other researchers is not intended.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No