Walking Pattern Characteristics in Normal Pressure Hydrocephalus

Not Applicable

Completed

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

• Registration Number: NCT04702035
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Status Verified: 2024-04
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNPH patients	Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)	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.
Young healthy volunteers	Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)	20 volunteers, matched with group 1 concerning sex only and between 18 and 40 years old.
Healthy volunteers	Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)	20 volunteers, matched with group 1 concerning sex and age.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time from appearance of first symptoms to surgery	before surgery	From first appearance of symptoms to surgery in years
3-dimensional characterization of walking patterns	after surgery (range 2 weeks to 6 months)	Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Kiefer score	after surgery (range 2 weeks to 6 months)	Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Stein and Langfitt score	after surgery (range 2 weeks to 6 months)	Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
4 minutes timed Walk test	immediately after fixation of IMUs	Standard test (seconds)
Evan´s Index	before surgery	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
NPH recovery rate	after surgery (range 2 weeks to 6 months)	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
Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign	before surgery	Positivity of standard sign in preoperative CT or MRI imaging, hinting at presence of iNPH. Values: Positive/Negative
180 degree turnaround test	immediately after fixation of IMUs	Participants are asked to turn by 180 degrees. Steps needed are counted.

Trial Locations

Locations (1)

Dept. of Neurosurgery, Zurich University Hospital; 🇨🇭 Zurich, Switzerland