Idiopathic Normal Pressure Hydrocephalus (INPH)NPH wearablesNCT04702035
Walking Pattern Characteristics in Normal Pressure Hydrocephalus
A study testing Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) in people with Idiopathic Normal Pressure Hydrocephalus (INPH), run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (INPH)
- What is being tested?
- Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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)
- Age between 18 and 40 years
- No clinical suspect for NPH or any other movement disorder
Who cannot join
- Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Neurosurgery, Zurich University Hospital
Zurich, 8091
About this study
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
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.
Read the 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.
- Being tested
- Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking characteristics
Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)
Measured: Between 2 weeks to 6 months after CSF diversion surgery
Secondary outcomes (12)
4 minutes timed Walk test
Standard test (seconds)
Measured: immediately after fixation of IMUs
180 degree turnaround test
Participants are asked to turn by 180 degrees. Steps needed are counted.
Measured: immediately after fixation of IMUs
Kiefer score
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Measured: before surgery
Kiefer score
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Measured: 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
Measured: before surgery
Stein and Langfitt score
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
Measured: 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
Measured: 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
Measured: 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
Measured: before surgery
Time from appearance of first symptoms to surgery
From first appearance of symptoms to surgery in years
Measured: before surgery
3-dimensional characterization of walking patterns
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Measured: before surgery
3-dimensional characterization of walking patterns
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Measured: after surgery (range 2 weeks to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jan 2018
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Normal Pressure Hydrocephalus (INPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of individuals are enrolled in parralel: 20 iNPH patients, 20 age- and gender-matched healthy individuals and 20 young individuals.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702035
- Sponsor's protocol ID
- NPH wearables
- Acronym
- NPH wearables
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2020
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of data with other researchers is not intended.
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.
PubMed 32153420
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04702035
- Acronym / sponsor ID
- NPH wearables / NPH wearables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups of individuals are enrolled in parralel: 20 iNPH patients, 20 age- and gender-matched healthy individuals and 20 young individuals.
| Arm | Type | Receives |
|---|---|---|
| iNPH patients | Experimental | Device: 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. |
| Healthy volunteers | Active comparator | Device: Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)20 volunteers, matched with group 1 concerning sex and age. |
| Young healthy volunteers | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (6 listed)
- Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy volunteers, Young healthy volunteers, iNPH patients |
Primary outcome
Walking characteristics
Time frame: Between 2 weeks to 6 months after CSF diversion surgery
Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)
12 secondary outcomes
4 minutes timed Walk test
Time frame: immediately after fixation of IMUs
180 degree turnaround test
Time frame: immediately after fixation of IMUs
Kiefer score
Time frame: before surgery
Kiefer score
Time frame: after surgery (range 2 weeks to 6 months)
Stein and Langfitt score
Time frame: before surgery
Stein and Langfitt score
Time frame: after surgery (range 2 weeks to 6 months)
NPH recovery rate
Time frame: after surgery (range 2 weeks to 6 months)
Evan´s Index
Time frame: before surgery
Disproportionally Enlarged Subarachnoidal space Hydrocephalus (DESH) sign
Time frame: before surgery
Time from appearance of first symptoms to surgery
Time frame: before surgery
3-dimensional characterization of walking patterns
Time frame: before surgery
3-dimensional characterization of walking patterns
Time frame: after surgery (range 2 weeks to 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Background: PubMed 32153420Renggli 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.
- Individual participant dataSharing planned: No. Sharing of data with other researchers is not intended.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors) in people with Idiopathic Normal Pressure Hydrocephalus (INPH), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking characteristics (time frame: Between 2 weeks to 6 months after CSF diversion surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04702035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.