HydrocephalusHPGAITNCT05998473
Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease
An observational study of Hydrocephalus and Parkinson Disease, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydrocephalus, Parkinson Disease, Walking, Difficulty
- What is being tested?
- Dynamic stability measurement
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Observational
- 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
Study population: Patients with normal pressure hydrocephalus or Parkinson's disease.
Who may be able to join
- Age >18 years
- Patient who performed a walking test in the Laboratory Analysis and Restoration of Movement
- Diagnosis of normal pressure hydrocephalus or Parkinson's disease
Who cannot join
- Levodopa drugs administrated during a delay of 12 hours before walking test
- Presence of an other neurologic disease or of any disease associated with motor disorders in lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.
Read the detailed description
Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait, similar to disorders in Parkinson's disease. No studies in the literature have focused on advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and in particular dynamic stability as part of additional assessments to help patients follow up. Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly benefit from these assessments. Retrospective analysis of all these data would help to better characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from those associated with Parkinson's disease. It would lead to the definition of relevant indices to be used for patient follow-up.
- Conditions
- Hydrocephalus, Parkinson Disease, Walking, Difficulty, Movement Disorders, Gait Ataxia, Diagnoses Disease
- Being tested
- Dynamic stability measurement
- Medical subject headings
- Hydrocephalus, Parkinson Disease, Mobility Limitation, Movement Disorders, Gait Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic stability measurementDiagnostic test
The subject is asked to walk 8 meters 3 times: at free speed, at fast speed, and with large steps.
| Study group | Role | What they receive |
|---|---|---|
| Normal pressure hydrocephalus | Patients with a diagnosis of normal pressure hydrocephalus and who performed a gait analysis in laboratories Receives: Diagnostic Test: Dynamic stability measurement | |
| Parkinson's disease | Patients with a diagnosis of Parkinson's disease and who performed a gait analysis in laboratories Receives: Diagnostic Test: Dynamic stability measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation in step length
Coefficient of variation in step length during 8-meter comfortable walking test
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Hutin, Henri Mondor University Hospital
- Investigators
- Emilie Hutin, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998473
- Sponsor's protocol ID
- 2023-A01762-43
- Acronym
- HPGAIT
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05998473
- Acronym / sponsor ID
- HPGAIT / 2023-A01762-43
- Conditions
- Hydrocephalus, Parkinson Disease, Walking, Difficulty, Movement Disorders, Gait Ataxia, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Aug 2023 (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.
This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.
Detailed description
Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait, similar to disorders in Parkinson's disease. No studies in the literature have focused on advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and in particular dynamic stability as part of additional assessments to help patients follow up. Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly benefit from these assessments. Retrospective analysis of all these data would help to better characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from those associated with Parkinson's disease. It would lead to the definition of relevant indices to be used for patient follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pressure hydrocephalus | – | Diagnostic Test: Dynamic stability measurementPatients with a diagnosis of normal pressure hydrocephalus and who performed a gait analysis in laboratories |
| Parkinson's disease | – | Diagnostic Test: Dynamic stability measurementPatients with a diagnosis of Parkinson's disease and who performed a gait analysis in laboratories |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with normal pressure hydrocephalus or Parkinson's disease.
Key inclusion criteria (3 listed)
- Age >18 years
- Patient who performed a walking test in the Laboratory Analysis and Restoration of Movement
- Diagnosis of normal pressure hydrocephalus or Parkinson's disease
Key exclusion criteria (2 listed)
- Levodopa drugs administrated during a delay of 12 hours before walking test
- Presence of an other neurologic disease or of any disease associated with motor disorders in lower limb.
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 |
|---|---|---|
| Dynamic stability measurementThe subject is asked to walk 8 meters 3 times: at free speed, at fast speed, and with large steps. | Diagnostic test | Normal pressure hydrocephalus, Parkinson's disease |
Primary outcome
Coefficient of variation in step length
Time frame: 30 seconds
Coefficient of variation in step length during 8-meter comfortable walking test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Emilie Hutin principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Parkinson Disease, run by Henri Mondor University Hospital at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 France. 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?
Results are not available in the source record.
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?
Coefficient of variation in step length (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.