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

Overview

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.

Interventions

• 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 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

Primary outcome measures

• Precision [Time frame: Through study completion, an average of 15+/-7 days]

Secondary outcome measures (5)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Rennes University Hospital — Rennes

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. PMID 39913915

Identifiers

NCT: NCT05822258 · 35RC22_9907-12_DetectFoG · 2023-A00561-44 · 23.01067.000298

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗