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

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Walk under 3 conditions (normal, physical tasks, verbal tasks)
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Freezing of Gait

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Freezing of Gait

Arm Description

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 tray with a plastic cup filled with water Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter. Passing conditions will be randomized. Each condition will be fulfilled a maximum of 5 times. A rest period will be respected

Outcomes

Primary Outcome Measures

Precision
The precision will be calculated as the ratio of the number of true positives and the number of true negatives. The reference identification of FOG episodes will be carried out on video by two expert neurologists.

Secondary Outcome Measures

Sensibility
Sensitivity will be calculated as the ratio of true positives divided by the sum of true positives and false negatives.
Accuracy
Accuracy will be calculated as the ratio of true positives divided by the sum of true positives and false positives.
Specificity
The specificity will be calculated as the ratio of true negatives divided by the sum of true negatives and false positives.
Average of the temporal difference between the beginning of the episode detected with video and that detected with the algorithm
Temporal difference between the beginning of the episode detected with video and that detected with the algorithm
Performance
Comparison of the performance of the algorithm (precision, sensitivity, accuracy, specificity) depending on the ON/OFF state and 3 path conditions, with a repeated measures ANOVA.

Full Information

First Posted
March 23, 2023
Last Updated
April 7, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05822258
Brief Title
DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units
Acronym
DetectFoG
Official Title
DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Freezing of Gait

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Freezing of Gait
Arm Type
Experimental
Arm Description
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 tray with a plastic cup filled with water Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter. Passing conditions will be randomized. Each condition will be fulfilled a maximum of 5 times. A rest period will be respected
Intervention Type
Other
Intervention Name(s)
Walk under 3 conditions (normal, physical tasks, verbal tasks)
Intervention Description
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 tray with a plastic cup filled with water Condition with added verbal tasks: The verbal task of saying as many words as possible starting with a specific letter. Passing conditions will be randomized. Each condition will be fulfilled a maximum of 5 times. A rest period will be respected
Primary Outcome Measure Information:
Title
Precision
Description
The precision will be calculated as the ratio of the number of true positives and the number of true negatives. The reference identification of FOG episodes will be carried out on video by two expert neurologists.
Time Frame
Through study completion, an average of 15+/-7 days
Secondary Outcome Measure Information:
Title
Sensibility
Description
Sensitivity will be calculated as the ratio of true positives divided by the sum of true positives and false negatives.
Time Frame
Through study completion, an average of 15+/-7 days
Title
Accuracy
Description
Accuracy will be calculated as the ratio of true positives divided by the sum of true positives and false positives.
Time Frame
Through study completion, an average of 15+/-7 days
Title
Specificity
Description
The specificity will be calculated as the ratio of true negatives divided by the sum of true negatives and false positives.
Time Frame
Through study completion, an average of 15+/-7 days
Title
Average of the temporal difference between the beginning of the episode detected with video and that detected with the algorithm
Description
Temporal difference between the beginning of the episode detected with video and that detected with the algorithm
Time Frame
Through study completion, an average of 15+/-7 days
Title
Performance
Description
Comparison of the performance of the algorithm (precision, sensitivity, accuracy, specificity) depending on the ON/OFF state and 3 path conditions, with a repeated measures ANOVA.
Time Frame
Through study completion, an average of 15+/-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Brittany
ZIP/Postal Code
35000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Jamal, MD
Email
karim.jamal@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
karim.jamal@chu-rennes.fr, MD
First Name & Middle Initial & Last Name & Degree
Karim Jamal, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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