Clinical trial NCT04702035: Walking Pattern Characteristics in Normal Pressure Hydrocephalus
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
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2021-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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:

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

Primary outcomes:
measure: Walking characteristics
timeFrame: Between 2 weeks to 6 months after CSF diversion surgery
Secondary outcomes:
measure: 4 minutes timed Walk test
timeFrame: immediately after fixation of IMUs
measure: 180 degree turnaround test
timeFrame: immediately after fixation of IMUs
measure: Kiefer score
timeFrame: before surgery
measure: Kiefer score
timeFrame: after surgery (range 2 weeks to 6 months)
measure: Stein and Langfitt score
timeFrame: before surgery
measure: Stein and Langfitt score
timeFrame: after surgery (range 2 weeks to 6 months)
measure: NPH recovery rate
timeFrame: after surgery (range 2 weeks to 6 months)
measure: Evan´s Index
timeFrame: before surgery
measure: Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign
timeFrame: before surgery
measure: Time from appearance of first symptoms to surgery
timeFrame: before surgery
measure: 3-dimensional characterization of walking patterns
timeFrame: before surgery
measure: 3-dimensional characterization of walking patterns
timeFrame: after surgery (range 2 weeks to 6 months)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Dept. of Neurosurgery, Zurich University Hospital
Study officials:
References:
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.