Walking Pattern Characteristics in Normal Pressure Hydrocephalus

N/ACompletedNCT04702035

University of Zurich60 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Neurosurgery, Zurich University Hospital

Zurich, Switzerland

Outcomes

Primary Outcomes

Walking characteristics

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 Outcomes

4 minutes timed Walk test

Standard test (seconds)

Time frame: immediately after fixation of IMUs

180 degree turnaround test

Participants are asked to turn by 180 degrees. Steps needed are counted.

Time frame: immediately after fixation of IMUs

Kiefer score

Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity

Time frame: before surgery

Kiefer score

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)

Stein and Langfitt score

Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency

Time frame: before surgery

Stein and Langfitt score

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)

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

Data from ClinicalTrials.gov

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