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

NCT ID: NCT05693207

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2023-12-23

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.

Detailed Description

The subject will arrive independently at the Tel Aviv Medical Center. After explaining the course of the study and signing a consent form, the subject will be administered the MoCA questionnaire to assess the cognitive state.

During this session, the patient will undergo gait evaluation using motion sensors and an EMG device.

This meeting will last up to an hour, according to the following breakdown:

Explanation of the test (10 min) Preparing the skin (light disinfection with alcohol) for EMG adhesion (10 min.) Performing of the test (20 minutes) Summary and discharge (5 min).

Conditions

Evaluation of Muscle Contraction in People With PD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

People with iPD with freezing of gait

Group Type: EXPERIMENTAL

EMG

Intervention Type: DEVICE

wearables EMG

People with iPD without freezing of gait

control group

Group Type: OTHER

EMG

Intervention Type: DEVICE

wearables EMG

Interventions

EMG

wearables EMG

Intervention Type: DEVICE

Other Intervention Names

Accelerometers and gyroscopes

Eligibility Criteria

Inclusion Criteria

1. Men and women aged 40-89.

2. 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.

3. 21 or above in MoCA test.

4. people who gave their written and oral consent to participate in the study.

1. Men and women aged 40-89.

2. 24 or above in MoCA test.

3. Without a neurological, cardiovascular or orthopedic disorder, which could affect the normal walking pattern, and all within the researcher's decision.

Criteria for exclusion from the experiment:

1. The patient has serious side effects that are not suitable for continuing in the study.

2. The patient does not wish to continue his participation in the study.

Exclusion Criteria

1. Neurological or other psychiatric disorder (such as MSA, PSP, after a stroke with neurological signs, dementia diseases, clinical depression) at the researcher's decision.

2. History of head injury - traumatic brain injury or cerebrovascular accident (CVA)

3. This study will not include pregnant women and children.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nir Giladi, Prof

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Tel-Aviv Sourasky Medical Center

Locations

Tel aviv medical center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Jeffrey Hausdorff, Phd

Role: CONTACT

jhausdor@tasmc.health.gov.il

972-3-6974958

David Buzaglo, B.pt

Role: CONTACT

davidbuz@tlvmc.gov.il

Facility Contacts

David Buzaglo, B.pt

Role: primary

davidbuz@tlvmc.gov.il

+972 36947513

Marina Brozgol, M.sc

Role: backup

marinab@tlvmc.gov.il

+972 36947513

References

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.

Reference Type: BACKGROUND

PMID: 24976103 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15300651 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28251357 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 33682729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32271717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30813411 (View on PubMed)

Other Identifiers

TASMC-21-NG-0515-CTIL

Identifier Type: -

Identifier Source: org_study_id