Assessing and Understanding Freezing of Gait at Home: FOG@Home

Study Overview
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Brief Summary
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Freezing of gait, (FOG) is an unpredictable, abrupt, short phenomenon that severely affects Parkinson's disease (PD) patients' gait and quality of life. The common measure tools are self-questioners that present the subjective feelings and the FOG provoking tests that used in clinic for evoking FOG and getting the estimated duration and the phenotype of the expressed phenomenon. The objective of this study is to investigate the FOG phenomenon using video cameras at patients' home with combination of wearable-axivity sensors and smart soles with a goal of objective assessment and quantification of freezing of gait severity in unsupervised daily-living environment of the PD patients.

Detailed Description
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30 PD subjects, referred by the Movement Disorders Centre would be enrolled in the study according to eligibility criteria. By prior arrangement, the researchers will arrive to the participant's home. After explanation and consent process, the participant would sign the consent form. At that point, the patient would be assessed, before the execution of the experimental protocol. Hoehn and Yahr staging (H&Y), Unified Parkinson's Disease Rating Scale (UPDRS) and common cognitive tests would be applied. Then, the participant would be ask to put the motion sensors (accelerometers) and place the cameras in strategic places in the house, where he expect to see most freezing of gait events while walking around the house (no bedrooms and bathrooms). After activating the systems, the researchers would go, leaving the video system and the sensors for 7 days (depending on the amount of received data) in the patient house.

Official Title
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Assessing and Understanding Freezing of Gait At-home Environment: FOG@Home

Conditions
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Parkinson Disease, Freezing of Gait

Intervention / Treatment
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* Device: AX6 6-axis logging accelerometer


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical diagnosis of Parkinson's disease (PD) according to the UK PD Society Brain Bank criteria; Modified Hoehn & Yahr Stage I to IV in the ON-state; Ability to walk 5 minutes while unassisted by another person; Mini-Mental State Examination (MMSE) score of >= 21 or > 16 on the 26-item MMSE screening; Self-reported freezing of gait (FOG) severity of at least 1 FOG episode per day, based on Characterizing of Freezing of Gait Questionnaire, irrespective of FOG occurring ON- or OFF-medication. Exclusion criteria: Acute musculoskeletal or other neurological or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent completing the protocol; The occurrence of any of the following within 3 months prior to informed consent: orthopedic surgery of the lower extremity, myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention, implantation of a cardiac resynchronization therapy device, implantation of deep brain stimulation; Substance abuse, major depressive disorder or clinical apathy that affects daily walking activity or may interfere with the patient's compliance; Inability to walk without a rollator indoors; Absence of clinically observed FOG during the FOG-provoking assessment.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOG@Home<br>Patients with Parkinson's disease who agreed to be monitored using cameras and acceleration measurements during daily life. | Device: AX6 6-axis logging accelerometer<br>* The device is collecting longitudinal movement data.<br>* Other names: AX6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent with FOG (% FOG) during the monitoring period | The percentage of time spent with FOG (%FOG) can be obtained as an outcome from standardized gait assessments that are video-taped and scored offline for FOG episodes by a trained expert. Freezing includes episodes of akinetic FOG, trembling FOG and festination. | immediate post monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accelerometer; Video; Freezing of gait; Parkinson's disease; Detection and Prediction of FOG