Parkinson DiseaseDetectFoGNCT05822258
DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units
A study testing Walk under 3 conditions (normal, physical tasks, verbal tasks) in people with Parkinson Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Walk under 3 conditions (normal, physical tasks, verbal tasks)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 8 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- With Parkinson's disease according to the United Kingdom Brain Bank criteria
- Presenting episodes of freezing of gait assessed on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS II - question 13 with a score between 1 and 3 in order to have a patient walking without technical assistance) produced by the neurologist
- Able to walk 30 meters independently
- Affiliated to a social security scheme or beneficiary of such a scheme
- Having signed a free and informed consent in writing
Who cannot join
- Montreal Cognitive Assessment (MOCA) < 20/30
- Other neurological or orthopedic history that interferes with walking
- Pregnant, parturient or breastfeeding women
- Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
- Persons undergoing psychiatric care, persons admitted to a health or social establishment for purposes other than research
- Minors
- Persons unable to express their consent
- Simultaneous participation in another research related to balance and/or walking
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rennes University Hospital
Rennes, Brittany Region, 35000
Karim Jamal, MD, 02 99 28 90 51 ext. 0033, karim.jamal@chu-rennes.fr
karim.jamal@chu-rennes.fr, MD
About this study
Official title: DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial
Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. It is defined as a brief and episodic absence or marked reduction in the forward progression of the feet despite the intention to walk. FOG is one of the most disabling symptoms causing a greater risk of falling and a loss of autonomy for these patients. This symptom is little or not dopamine-sensitive and little improved by surgery (deep brain stimulation).
Although this symptom is common and debilitating, it is difficult to assess clinically. The objective assessment of the presence and severity of FOG episodes can be done with tests such as the New-Freezing of Gait Questionnaire (N-FOGQ) with however limitations. Indeed, this filmed examination is scored a posteriori and the accumulation of the administration times which makes it difficult to use in routine clinical practice. To overcome these limitations, the use of a diary completed by the patient himself is a simple alternative to assess this symptom, but studies show that patients abandon this practice in the long term and that it is not used by patients with cognitive impairment.
Read more
Recent advances in miniaturization have made it possible to create light and compact sensors to assess these events objectively. Inertial measurement units have been widely used in the literature to detect FOG episodes. The choice of the detection algorithms are a major issue in the scientific community. To date, due to the heterogeneity of the protocols, no method is currently required as a reference.
The objective is to evaluate the accuracy of a new algorithm to detect the number of FOG episodes in Parkinsonian patients. This evaluation will be done on the freeze-inducing walking path.
- Conditions
- Parkinson Disease
- Being tested
- Walk under 3 conditions (normal, physical tasks, verbal tasks)
- Keywords
- Freezing of Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk under 3 conditions (normal, physical tasks, verbal tasks)Other
Each patient will have 2 visits :
- First visit in the "ON" state phase, i.e. when their oral treatment allows the maximum improvement of dopamine-responsive parkinsonian symptoms.
- A second visit will be scheduled 15 +/- 7 days from the first. Patients will then be assessed in the "OFF" phase after having stopped taking their antiparkinsonian medications for at least 12 hours before the start of the visit, in order to promote episodes of FOG
For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions:
- Normal condition without addition of additional physical and verbal tasks
- Condition with added physical tasks: The physical task of holding a ball in the center of a tray
- Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter.
Conditions of passage are randomized per patient. Each subject will complete the course a maximum of 18 times in blocks of 3 conditions.
| Study group | Role | What they receive |
|---|---|---|
| Freezing of Gait | Experimental | Each patient will have 2 visits :
* First visit in the "ON" state phase, i.e. when their oral treatment allows the maximum improvement of dopamine-responsive parkinsonian symptoms.
* A second visit in the "OFF" phase after having stopped taking their antiparkinsonian medications for at least 12 hours before the start of the visit, in order to promote episodes of FOG
For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions:
* Normal condition without additional physical and verbal tasks
* Condition with added physical tasks: The physical task of holding a ball in the center of a tray.
* Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter.
Conditions of passage are randomized per patient. Each subject will complete the course a maximum of 18 times in blocks of 3 conditions (normal, double physical task and double verbal task). A rest period will be observed. Receives: Other: Walk under 3 conditions (normal, physical tasks, verbal tasks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision
Every second of the course will be analyzed to define :
- the "true positive" time: FOG detected by the algorithm and the two experts
- True negative" time: FOG detected by neither the algorithm nor the two experts
- False positive" time: FOG detected by the algorithm but not by the two experts
- False negative" time: FOG not detected by the algorithm but detected by both experts For each course completed, accuracy will then be calculated as the ratio between the sum of the time spent in "true positive" and "true negative" divided by the time taken to complete the course.
The average of these ratios is then calculated to estimate the accuracy of all runs performed, i.e. taking into account all repetitions performed by patients, regardless of run type and ON/OFF status.
Measured: Through study completion, an average of 15+/-7 days
Secondary outcomes (5)
Sensitivity
Sensitivity will be calculated as the ratio of time spent in "true positive" divided by the sum of time spent in "true positive" and "false negative". These ratios will then be averaged to estimate accuracy over all the runs performed, i.e. taking into account all the repetitions performed by patients, regardless of run type and ON/OFF status.
Measured: Through study completion, an average of 15+/-7 days
Specificity
Specificity will be calculated as the ratio of time spent in "true negative" divided by the sum of time spent in "true negative" and "false positive". These ratios will then be averaged to estimate accuracy over all the runs performed, i.e. taking into account all the repetitions performed by patients, regardless of run type and ON/OFF status.
Measured: Through study completion, an average of 15+/-7 days
Positive predictive value (PPV)
The positive predictive value will be calculated as the ratio of time spent in "true positive" divided by the sum of time spent in "true positive" and "false positive". The average of these ratios will then be calculated to estimate the accuracy over all the runs performed, i.e. taking into account all the repetitions performed by patients, regardless of run type and ON/OFF status.
Measured: Through study completion, an average of 15+/-7 days
Negative predictive value (NPV)
The negative predictive value will be calculated as the ratio of time spent in "true negative" divided by the sum of time spent in "true negative" and "false negative". The average of these ratios will then be calculated to estimate the accuracy over all the runs performed, i.e. taking into account all the repetitions performed by patients, regardless of run type and ON/OFF status.
Measured: Through study completion, an average of 15+/-7 days
Time difference
The time difference between the start of the episode detected by the experts and that detected with the
Measured: Through study completion, an average of 15+/-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start8 Jan 2024
- Primary completion8 Feb 2026 (estimated)
- Study completion8 Aug 2026 (estimated)
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 Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Patients will be evaluated in the "ON" state phase and in the "OFF" state phase. For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions: motor task, verbal, normal.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822258
- Sponsor's protocol ID
- 35RC22_9907-12_DetectFoG
- Other IDs
- 2023-A00561-44, 23.01067.000298
- Acronym
- DetectFoG
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordillet S, Drapier S, Leh F, Dumont A, Bidet F, Bonan I, Jamal K. Detecting Freezing of Gait in Parkinson Disease Using Multiple Wearable Sensors Sets During Various Walking Tasks Relative to Medication Conditions (DetectFoG): Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Feb 6;14:e58612. doi: 10.2196/58612.
PubMed 39913915
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial
- ClinicalTrials.gov ID
- NCT05822258
- Acronym / sponsor ID
- DetectFoG / 35RC22_9907-12_DetectFoG
- Conditions
- Parkinson Disease
- Keywords
- Freezing of Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Feb 2026 (estimated)
- Study completion
- 8 Aug 2026 (estimated)
- First posted
- 20 Apr 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.
Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. It is defined as a brief and episodic absence or marked reduction in the forward progression of the feet despite the intention to walk. FOG is one of the most disabling symptoms causing a greater risk of falling and a loss of autonomy for these patients. This symptom is little or not dopamine-sensitive and little improved by surgery (deep brain stimulation).
Although this symptom is common and debilitating, it is difficult to assess clinically. The objective assessment of the presence and severity of FOG episodes can be done with tests such as the New-Freezing of Gait Questionnaire (N-FOGQ) with however limitations. Indeed, this filmed examination is scored a posteriori and the accumulation of the administration times which makes it difficult to use in routine clinical practice. To overcome these limitations, the use of a diary completed by the patient himself is a simple alternative to assess this symptom, but studies show that patients abandon this practice in the long term and that it is not used by patients with cognitive impairment.
Recent advances in miniaturization have made it possible to create light and compact sensors to assess these events objectively. Inertial measurement units have been widely used in the literature to detect FOG episodes. The choice of the detection algorithms are a major issue in the scientific community. To date, due to the heterogeneity of the protocols, no method is currently required as a reference.
The objective is to evaluate the accuracy of a new algorithm to detect the number of FOG episodes in Parkinsonian patients. This evaluation will be done on the freeze-inducing walking path.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be evaluated in the "ON" state phase and in the "OFF" state phase. For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions: motor task, verbal, normal.
| Arm | Type | Receives |
|---|---|---|
| Freezing of Gait | Experimental | Other: Walk under 3 conditions (normal, physical tasks, verbal tasks)Each patient will have 2 visits : * First visit in the "ON" state phase, i.e. when their oral treatment allows the maximum improvement of dopamine-responsive parkinsonian symptoms. * A second visit in the "OFF" phase after having stopped taking their antiparkinsonian medications for at least 12 hours before the start of the visit, in order to promote episodes of FOG For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions: * Normal condition without additional physical and verbal tasks * Condition with added physical tasks: The physical task of holding a ball in the center of a tray. * Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter. Conditions of passage are randomized per patient. Each subject will complete the course a maximum of 18 times in blocks of 3 conditions (normal, double physical task and double verbal task). A rest period will be observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 18 years old
- With Parkinson's disease according to the United Kingdom Brain Bank criteria
- Presenting episodes of freezing of gait assessed on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS II - question 13 with a score between 1 and 3 in order to have a patient walking without technical assistance) produced by the neurologist
- Able to walk 30 meters independently
- Affiliated to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (8 listed)
- Montreal Cognitive Assessment (MOCA) < 20/30
- Other neurological or orthopedic history that interferes with walking
- Pregnant, parturient or breastfeeding women
- Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
- Persons undergoing psychiatric care, persons admitted to a health or social establishment for purposes other than research
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 |
|---|---|---|
| Walk under 3 conditions (normal, physical tasks, verbal tasks)Each patient will have 2 visits : * First visit in the "ON" state phase, i.e. when their oral treatment allows the maximum improvement of dopamine-responsive parkinsonian symptoms. * A second visit will be scheduled 15 +/- 7 days from the first. Patients will then be assessed in the "OFF" phase after having stopped taking their antiparkinsonian medications for at least 12 hours before the start of the visit, in order to promote episodes of FOG For each visit, the patient will be asked to walk at a comfortable speed under the following 3 conditions: * Normal condition without addition of additional physical and verbal tasks * Condition with added physical tasks: The physical task of holding a ball in the center of a tray * Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter. Conditions of passage are randomized per patient. Each subject will complete the course a maximum of 18 times in blocks of 3 conditions. | Other | Freezing of Gait |
Primary outcome
Precision
Time frame: Through study completion, an average of 15+/-7 days
Every second of the course will be analyzed to define : * the "true positive" time: FOG detected by the algorithm and the two experts * True negative" time: FOG detected by neither the algorithm nor the two experts * False positive" time: FOG detected by the algorithm but not by the two experts * False negative" time: FOG not detected by the algorithm but detected by both experts For each course completed, accuracy will then be calculated as the ratio between the sum of the time spent in "true positive" and "true negative" divided by the time taken to complete the course. The average of these ratios is then calculated to estimate the accuracy of all runs performed, i.e. taking into account all repetitions performed by patients, regardless of run type and ON/OFF status.
5 secondary outcomes
Sensitivity
Time frame: Through study completion, an average of 15+/-7 days
Specificity
Time frame: Through study completion, an average of 15+/-7 days
Positive predictive value (PPV)
Time frame: Through study completion, an average of 15+/-7 days
Negative predictive value (NPV)
Time frame: Through study completion, an average of 15+/-7 days
Time difference
Time frame: Through study completion, an average of 15+/-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 39913915Cordillet S, Drapier S, Leh F, Dumont A, Bidet F, Bonan I, Jamal K. Detecting Freezing of Gait in Parkinson Disease Using Multiple Wearable Sensors Sets During Various Walking Tasks Relative to Medication Conditions (DetectFoG): Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Feb 6;14:e58612. doi: 10.2196/58612.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk under 3 conditions (normal, physical tasks, verbal tasks) in people with Parkinson Disease, run by Rennes 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 6 inclusion and 8 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 9 Oct 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision (time frame: Through study completion, an average of 15+/-7 days). 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 NCT05822258, 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 9 Oct 2024.