Back to resultsAssessing and Understanding Freezing of Gait at Home: FOG@Home
Primary Purpose
Parkinson Disease, Freezing of Gait
Status
Not yet recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AX6 6-axis logging accelerometer
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Accelerometer; Video; Freezing of gait; Parkinson's disease; Detection and Prediction of FOG
Eligibility Criteria
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.
Sites / Locations
- Movement disorders unit, the Department of Neurology, Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOG@Home
Arm Description
Patients with Parkinson's disease who agreed to be monitored using cameras and acceleration measurements during daily life.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05718739
First Posted
January 30, 2023
Last Updated
January 30, 2023
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05718739
Brief Title
Assessing and Understanding Freezing of Gait at Home: FOG@Home
Official Title
Assessing and Understanding Freezing of Gait At-home Environment: FOG@Home
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Freezing of Gait
Keywords
Accelerometer; Video; Freezing of gait; Parkinson's disease; Detection and Prediction of FOG
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOG@Home
Arm Type
Experimental
Arm Description
Patients with Parkinson's disease who agreed to be monitored using cameras and acceleration measurements during daily life.
Intervention Type
Device
Intervention Name(s)
AX6 6-axis logging accelerometer
Other Intervention Name(s)
AX6
Intervention Description
The device is collecting longitudinal movement data.
Primary Outcome Measure Information:
Title
Percentage of time spent with FOG (% FOG) during the monitoring period
Description
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.
Time Frame
immediate post monitoring
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Brozgol, PhD
Phone
+69236947513
Email
marinab@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Alcalay, MD
Organizational Affiliation
Director of the Center for Movement Disorders, Neurological Department, Tel Aviv Sourasky Medical Center - Ichilov Hospital, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Movement disorders unit, the Department of Neurology, Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18668629
Citation
Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40.
Results Reference
background
PubMed Identifier
31771246
Citation
Pardoel S, Kofman J, Nantel J, Lemaire ED. Wearable-Sensor-based Detection and Prediction of Freezing of Gait in Parkinson's Disease: A Review. Sensors (Basel). 2019 Nov 24;19(23):5141. doi: 10.3390/s19235141.
Results Reference
result
PubMed Identifier
31524181
Citation
Gilat M. How to Annotate Freezing of Gait from Video: A Standardized Method Using Open-Source Software. J Parkinsons Dis. 2019;9(4):821-824. doi: 10.3233/JPD-191700.
Results Reference
result
PubMed Identifier
34816053
Citation
Zoetewei D, Herman T, Brozgol M, Ginis P, Thumm PC, Ceulemans E, Decaluwe E, Palmerini L, Ferrari A, Nieuwboer A, Hausdorff JM. Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease. Contemp Clin Trials Commun. 2021 Jun 29;24:100817. doi: 10.1016/j.conctc.2021.100817. eCollection 2021 Dec.
Results Reference
result
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Assessing and Understanding Freezing of Gait at Home: FOG@Home
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