EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease

NCT05693207 | Unknown

• 1 other identifier: TASMC-21-NG-0515-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. The phenomenon of FOG appears in advanced cases of Parkinson's disease (PD) and can lead to an increased risk of falls. There are several approaches claiming that there is abnormal activity in the calf muscles and the freezing events in Parkinson's patients. In the clinic, monitoring FOG is done subjectively, usually through observations or through questionnaires. As a result, the information about the phenomenon may be biased and insensitive. With an electromyographic monitor (EMG), objective information about the muscular activity during normal walking and during unusual events can be obtained.

Conditions

Evaluation of Muscle Contraction in People With PD

Outcome Measures

Primary Outcomes (1)

• Percentage time of co-contractions

  The time of co-contraction during walking will be higher among people with FOG.

  60 minutes

Study Arms (2)

People with iPD with freezing of gait

EXPERIMENTAL

Device: EMG

People with iPD without freezing of gait

OTHER

control group

Device: EMG

Interventions

EMG DEVICE

wearables EMG

Also known as: Accelerometers and gyroscopes

People with iPD with freezing of gait; People with iPD without freezing of gait

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 40-89.
• Patients with idiopathic Parkinson's disease according to the diagnosis of a neurologist, who are able to walk with or without a walking aid for at least 5 minutes.
• or above in MoCA test.
• people who gave their written and oral consent to participate in the study.
• Men and women aged 40-89.
• or above in MoCA test.
• Without a neurological, cardiovascular or orthopedic disorder, which could affect the normal walking pattern, and all within the researcher's decision.
• The patient has serious side effects that are not suitable for continuing in the study.
• The patient does not wish to continue his participation in the study.

You may not qualify if:

• Neurological or other psychiatric disorder (such as MSA, PSP, after a stroke with neurological signs, dementia diseases, clinical depression) at the researcher's decision.
• History of head injury - traumatic brain injury or cerebrovascular accident (CVA)
• This study will not include pregnant women and children.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel aviv medical center

Tel Aviv, Israel

RECRUITING

Related Publications (6)

• Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.

  PMID: 24976103 BACKGROUND

• Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115.

  PMID: 15300651 BACKGROUND

• Silva de Lima AL, Evers LJW, Hahn T, Bataille L, Hamilton JL, Little MA, Okuma Y, Bloem BR, Faber MJ. Freezing of gait and fall detection in Parkinson's disease using wearable sensors: a systematic review. J Neurol. 2017 Aug;264(8):1642-1654. doi: 10.1007/s00415-017-8424-0. Epub 2017 Mar 1.

  PMID: 28251357 BACKGROUND

• Hanein Y, Mirelman A. The Home-Based Sleep Laboratory. J Parkinsons Dis. 2021;11(s1):S71-S76. doi: 10.3233/JPD-202412.

  PMID: 33682729 BACKGROUND

• Inzelberg L, David-Pur M, Gur E, Hanein Y. Multi-channel electromyography-based mapping of spontaneous smiles. J Neural Eng. 2020 Apr 9;17(2):026025. doi: 10.1088/1741-2552/ab7c18.

  PMID: 32271717 BACKGROUND

• Mazzetta I, Zampogna A, Suppa A, Gumiero A, Pessione M, Irrera F. Wearable Sensors System for an Improved Analysis of Freezing of Gait in Parkinson's Disease Using Electromyography and Inertial Signals. Sensors (Basel). 2019 Feb 23;19(4):948. doi: 10.3390/s19040948.

  PMID: 30813411 BACKGROUND

Study Officials

• Nir Giladi, Prof

  Study Principal Investigator Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Hausdorff, Phd

CONTACT

972-3-6974958; jhausdor@tasmc.health.gov.il

David Buzaglo, B.pt

CONTACT

davidbuz@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 20, 2023
• Study Start: October 7, 2021
• Primary Completion: May 23, 2023
• Study Completion: December 23, 2023
• Last Updated: January 20, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)