Clinical trial NCT05822258: DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units
Official title: DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Freezing of Gait
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Precision
timeFrame: Through study completion, an average of 15+/-7 days
Secondary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 15+/-7 days
measure: Specificity
timeFrame: Through study completion, an average of 15+/-7 days
measure: Positive predictive value (PPV)
timeFrame: Through study completion, an average of 15+/-7 days
measure: Negative predictive value (NPV)
timeFrame: Through study completion, an average of 15+/-7 days
measure: Time difference
timeFrame: Through study completion, an average of 15+/-7 days
Other outcomes:
measure: Ability to generate FOG episodes between different pathway modalities
timeFrame: Through study completion, an average of 15+/-7 days
measure: Ability to generate FOG episodes according to medical conditions (ON/OFF)
timeFrame: Through study completion, an average of 15+/-7 days
measure: Algorithm performance according to pathway
timeFrame: Through study completion, an average of 15+/-7 days
measure: Algorithm performance according to medical conditions (ON/OFF)
timeFrame: Through study completion, an average of 15+/-7 days
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
Study officials:
References: