Parkinson DiseaseGAIT-PDNCT05908279
Gait Control in Parkinson Disease
An observational study of Parkinson Disease, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Walking test and Disease assessement
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2023to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: One group of volunteers with previous diagnosis of Parkinson disease and one group of age and sex matched healthy volunteers.
Who may be able to join
- Patients and volunteers able to walk for 20mins and without other neurological disorders.
Who cannot join
- Patients or volunteers unable to walk for 20mins and with other neurological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Frederic Crevecoeur contact
Belgium1 site, 1 recruiting
- Recruiting
Université catholique de Louvain
Louvain-la-Neuve, 1348
Andre Mouraux, PhD, +32 2 764 54 47, andre.mouraux@uclouvain.be
About this study
Official title: Flexible Control of Gait in Parkinson Disease: Effect of Task Instruction on the Exploitation of Redundancy in Speed Control.
Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.
- Conditions
- Parkinson Disease
- Being tested
- Walking test, Disease assessement
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking testOther
Walk with and without a metronome
Disease assessementOther
Disease stage assessed by a doctor
| Study group | Role | What they receive |
|---|---|---|
| PD | Patients with Parkinson's disease Receives: Other: Walking test; Other: Disease assessement | |
| Control | Healthy volunteers Receives: Other: Walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride cadence
Time between two consecutive heel strikes. Units are seconds.
Measured: Measured during the entire experiment (an average of 4.5 years)
Stride amplitude
Distance between two consecutive heel strikes. Units are meters.
Measured: Measured during the entire experiment (an average of 4.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 May 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Crevecoeur, Study director, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908279
- Sponsor's protocol ID
- GAIT-PD
- Acronym
- GAIT-PD
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 18 Jun 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Control of Gait in Parkinson Disease: Effect of Task Instruction on the Exploitation of Redundancy in Speed Control.
- ClinicalTrials.gov ID
- NCT05908279
- Acronym / sponsor ID
- GAIT-PD / GAIT-PD
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Jun 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.
Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD | – | Other: Walking test, Other: Disease assessementPatients with Parkinson's disease |
| Control | – | Other: Walking testHealthy volunteers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One group of volunteers with previous diagnosis of Parkinson disease and one group of age and sex matched healthy volunteers.
Key inclusion criteria (1 listed)
- Patients and volunteers able to walk for 20mins and without other neurological disorders.
Key exclusion criteria (1 listed)
- Patients or volunteers unable to walk for 20mins and with other neurological disorders.
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 |
|---|---|---|
| Walking testWalk with and without a metronome | Other | Control, PD |
| Disease assessementDisease stage assessed by a doctor | Other | PD |
Primary outcome
Stride cadence
Time frame: Measured during the entire experiment (an average of 4.5 years)
Time between two consecutive heel strikes. Units are seconds.
Stride amplitude
Time frame: Measured during the entire experiment (an average of 4.5 years)
Distance between two consecutive heel strikes. Units are meters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
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.
Frederic Crevecoeur contact
Frederic Crevecoeur study director
Université Catholique de Louvain
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 Parkinson Disease, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Jun 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact André Mouraux, PhD (+32 2 764 54 47, andre.mouraux@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride cadence (time frame: Measured during the entire experiment (an average of 4.5 years)). The study lists 2 primary outcomes in all. 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 18 Jun 2023.