DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units

NCT05822258 | Recruiting

• 3 other identifiers: 35RC22_9907-12_DetectFoG2023-A00561-4423.01067.000298
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Freezing of Gait

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 15+/-7 days

Secondary Outcomes (5)

• Sensitivity

  Through study completion, an average of 15+/-7 days

• Specificity

  Through study completion, an average of 15+/-7 days

• Positive predictive value (PPV)

  Through study completion, an average of 15+/-7 days

• Negative predictive value (NPV)

  Through study completion, an average of 15+/-7 days

• Time difference

  Through study completion, an average of 15+/-7 days

Other Outcomes (4)

• Ability to generate FOG episodes between different pathway modalities

  Through study completion, an average of 15+/-7 days

• Ability to generate FOG episodes according to medical conditions (ON/OFF)

  Through study completion, an average of 15+/-7 days

• Algorithm performance according to pathway

  Through study completion, an average of 15+/-7 days

Study Arms (1)

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.

Other: Walk under 3 conditions (normal, physical tasks, verbal tasks)

Interventions

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.

Freezing of Gait

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35000, France

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 20, 2023
• Study Start: January 8, 2024
• Primary Completion: February 8, 2026
• Study Completion (Estimated): August 8, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)