Parkinson DiseasedemarparkNCT02317289
Assisted Device for Freezing in Parkinson Disease
A study testing Detection of freezing in people with Parkinson Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Detection of freezing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2014to 13 Oct 2015
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- troublesome freezing
Who cannot join
- dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients
Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.
Read the detailed description
Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients .This brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk is associated to a fall risk. Automatized FOG episode detection would allow systematic assessment of patient state and objective evaluation of the clinical effects of treatments. Techniques have been proposed in the literature to identify FOG episodes based on the frequency properties of inertial sensor signals. Our objective here is to adapt and extend these FOG detectors in order to include other associated gait pattern changes, like festination. The proposed approach is based on a single wireless inertial sensor placed on the patient's lower limbs. Based freezing detectors are not sufficient to detect all FOG and festination episodes. Stride length and cadence are valuable inputs to anticipate the occurrence of upcoming FOG events. The investigators have developed a solution based on a minimal number of embedded sensors and detection algorithms for future real-time applications. It is well known that auditory rhythmic stimulation or visuals marks on the ground would improve dramatically gait in patients with FOG. This sensibility to cueing leads some teams to develop some mobility aid devices rhythmic. Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.
- Conditions
- Parkinson Disease
- Being tested
- Detection of freezing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of freezingDevice
Also called SENSBIO
single wireless inertial sensor placed on the patients's lower limbs to detect freezing of gaitin Parkinsonian patients
| Study group | Role | What they receive |
|---|---|---|
| Detection of freezing | Experimental | freezing parkinsonian patients Receives: Device: Detection of freezing |
What is being measured
The primary outcome is the main question the study is designed to answer.
fog score
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study start6 Jun 2014
- Primary completion13 Oct 2015
- Study completion13 Oct 2015
Why it stopped: end of inclusion period and recruitment difficulties
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 University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian GENY, MD, Principal investigator, CHRU Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317289
- Sponsor's protocol ID
- 9096
- Acronym
- demarpark
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2014
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients
- ClinicalTrials.gov ID
- NCT02317289
- Acronym / sponsor ID
- demarpark / 9096
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of inclusion period and recruitment difficulties
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Jun 2014 (actual)
- Primary completion
- 13 Oct 2015 (actual)
- Study completion
- 13 Oct 2015 (actual)
- First posted
- 15 Dec 2014 (estimated)
- 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.
Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.
Detailed description
Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients .This brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk is associated to a fall risk. Automatized FOG episode detection would allow systematic assessment of patient state and objective evaluation of the clinical effects of treatments. Techniques have been proposed in the literature to identify FOG episodes based on the frequency properties of inertial sensor signals. Our objective here is to adapt and extend these FOG detectors in order to include other associated gait pattern changes, like festination. The proposed approach is based on a single wireless inertial sensor placed on the patient's lower limbs. Based freezing detectors are not sufficient to detect all FOG and festination episodes. Stride length and cadence are valuable inputs to anticipate the occurrence of upcoming FOG events. The investigators have developed a solution based on a minimal number of embedded sensors and detection algorithms for future real-time applications. It is well known that auditory rhythmic stimulation or visuals marks on the ground would improve dramatically gait in patients with FOG. This sensibility to cueing leads some teams to develop some mobility aid devices rhythmic. Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Detection of freezing | Experimental | Device: Detection of freezingfreezing parkinsonian patients |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- troublesome freezing
Key exclusion criteria (1 listed)
- dementia
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 |
|---|---|---|
| Detection of freezingAlso: SENSBIOsingle wireless inertial sensor placed on the patients's lower limbs to detect freezing of gaitin Parkinsonian patients | Device | Detection of freezing |
Primary outcome
fog score
Time frame: 1 day
Results and safety
The study was stopped early (reason given: end of inclusion period and recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
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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.
Christian GENY, MD principal investigator
CHRU Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of freezing in people with Parkinson Disease, run by University Hospital, Montpellier 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 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: stopped early, as of the sponsor's last update on 28 Dec 2021. 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?
The study was stopped early (reason given: end of inclusion period and recruitment difficulties). 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?
fog score (time frame: 1 day). 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 28 Dec 2021.