Walking Pattern Characteristics in Normal Pressure Hydrocephalus

NCT04702035 | Completed

• 1 other identifier: NPH wearables
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 4 minutes timed Walk test

  immediately after fixation of IMUs

• 180 degree turnaround test

  immediately after fixation of IMUs

• Kiefer score

  before surgery

• Kiefer score

  after surgery (range 2 weeks to 6 months)

• Stein and Langfitt score

  before surgery

Study Arms (3)

iNPH patients

EXPERIMENTAL

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)

Healthy volunteers

ACTIVE COMPARATOR

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)

Young healthy volunteers

ACTIVE COMPARATOR

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)

Interventions

Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) DEVICE

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.

Healthy volunteers; Young healthy volunteers; iNPH patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• ETH Zurich: collaborator

Study Sites (1)

Dept. of Neurosurgery, Zurich University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32153420 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: unmasked
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups of individuals are enrolled in parralel: 20 iNPH patients, 20 age- and gender-matched healthy individuals and 20 young individuals.

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: January 8, 2021
• Study Start: January 1, 2018
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)