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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05718739
• Other study ID #: TASMC-23-RE-0072-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Marina Brozgol, PhD
• Phone: +69236947513
• Email: marinab[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

Device:
• AX6 6-axis logging accelerometer
The device is collecting longitudinal movement data.

Locations

Country	Name	City	State
Israel	Movement disorders unit, the Department of Neurology, Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View 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. — View 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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