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

NCT05718739 | Unknown

• 1 other identifier: TASMC-23-RE-0072-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Accelerometer; Video; Freezing of gait; Parkinson's disease; Detection and Prediction of FOG

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

FOG@Home

EXPERIMENTAL

Patients with Parkinson's disease who agreed to be monitored using cameras and acceleration measurements during daily life.

Device: AX6 6-axis logging accelerometer

Interventions

AX6 6-axis logging accelerometer DEVICE

The device is collecting longitudinal movement data.

Also known as: AX6

FOG@Home

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Movement disorders unit, the Department of Neurology, Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related 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.

  PMID: 18668629 BACKGROUND

• 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.

  PMID: 31771246 RESULT

• 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.

  PMID: 31524181 RESULT

• 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.

  PMID: 34816053 RESULT

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 Officials

• Roy Alcalay, MD

  Director of the Center for Movement Disorders, Neurological Department, Tel Aviv Sourasky Medical Center - Ichilov Hospital, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Brozgol, PhD

CONTACT

+69236947513; marinab@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)