Back to resultsEMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease
Primary Purpose
Evaluation of Muscle Contraction in People With PD
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EMG
Sponsored by
About this trial
This is an interventional diagnostic trial for Evaluation of Muscle Contraction in People With PD
Eligibility Criteria
Inclusion criteria for patients: 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. 21 or above in MoCA test. people who gave their written and oral consent to participate in the study. Inclusion criteria for healthy people: Men and women aged 40-89. 24 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. Criteria for exclusion from the experiment: 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. Exclusion criteria for Parkinson's patients: 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.
Sites / Locations
- Tel aviv medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
People with iPD with freezing of gait
People with iPD without freezing of gait
Arm Description
control group
Outcomes
Primary Outcome Measures
Percentage time of co-contractions
The time of co-contraction during walking will be higher among people with FOG.
Secondary Outcome Measures
Full Information
NCT ID
NCT05693207
First Posted
December 27, 2022
Last Updated
January 12, 2023
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05693207
Brief Title
EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease
Official Title
EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
May 23, 2023 (Anticipated)
Study Completion Date
December 23, 2023 (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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluation of Muscle Contraction in People With PD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
People with iPD with freezing of gait
Arm Type
Experimental
Arm Title
People with iPD without freezing of gait
Arm Type
Other
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
EMG
Other Intervention Name(s)
Accelerometers and gyroscopes
Intervention Description
wearables EMG
Primary Outcome Measure Information:
Title
Percentage time of co-contractions
Description
The time of co-contraction during walking will be higher among people with FOG.
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for patients:
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.
21 or above in MoCA test.
people who gave their written and oral consent to participate in the study.
Inclusion criteria for healthy people:
Men and women aged 40-89.
24 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.
Criteria for exclusion from the experiment:
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.
Exclusion criteria for Parkinson's patients:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Hausdorff, Phd
Phone
972-3-6974958
Email
jhausdor@tasmc.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
David Buzaglo, B.pt
Email
davidbuz@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Giladi, Prof
Organizational Affiliation
Study Principal Investigator Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel aviv medical center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Buzaglo, B.pt
Phone
+972 36947513
Email
davidbuz@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Marina Brozgol, M.sc
Phone
+972 36947513
Email
marinab@tlvmc.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24976103
Citation
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.
Results Reference
background
PubMed Identifier
15300651
Citation
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.
Results Reference
background
PubMed Identifier
28251357
Citation
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.
Results Reference
background
PubMed Identifier
33682729
Citation
Hanein Y, Mirelman A. The Home-Based Sleep Laboratory. J Parkinsons Dis. 2021;11(s1):S71-S76. doi: 10.3233/JPD-202412.
Results Reference
background
PubMed Identifier
32271717
Citation
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.
Results Reference
background
PubMed Identifier
30813411
Citation
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.
Results Reference
background
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EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease
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