- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099132
Antagonist Activation Measurement at the Ankle Using High-density and Bipolar Surface EMG in Chronic Hemiparesis (CC2017)
October 19, 2023 updated by: Emilie Hutin, Henri Mondor University Hospital
In chronic hemiparesis, abnormal antagonist muscle activation in the paretic lower limb contributes to impair ambulation capacities.
A biased estimate of antagonist muscle activation when using surface bipolar EMG compared with high-density (HD) EMG has been previously reported in healthy subjects.
The present study compares muscles cocontraction at the paretic ankle estimated with a pair of and multi-channel surface EMG.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In chronic hemiparesis, gait velocity deficit is associated with a disturbed voluntary movement caused especially by inappropriate antagonist muscle activation.
The present study investigates muscles cocontraction at the paretic ankle estimated with a pair of and multi-channel surface EMG (HD-EMG) in patients after stroke.
HD-EMGs were collected from gastrocnemius medialis (GM), tibialis anterior (TA) and soleus (SO) during isometric contractions.
From these EMGs the study asked whether bipolar and HD-EMGs provided comparable estimates of antagonist activation.
Two active contraction levels (submaximal vs. maximal) and knee positions (flexed vs. extended) were assessed for each muscle.
Notwithstanding the evidence of localized antagonist activation in the GM muscle of healthy subjects, hypothesizing equally localized antagonist activation in the paretic limb may not follow from the current literature.
In virtue of evidence supporting the enlargement of motor unit territories in paretic and hyperactive muscles, it may be that stroke survivors have lost their ability to regionally and appropriately activate their muscle.
In this case, bipolar and HD-EMG would be expected to provide comparable antagonist activation coefficients.
Study Type
Observational
Enrollment (Actual)
12
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Person with chronic hemiparesis due to a non-evolutive central nervous system lesion
Description
Inclusion Criteria:
- hemiparesis due to a non-evolutive central nervous system lesion
- time since lesion ≥ 6 months
- ability to walk 10 meters barefoot without any assistance
- cognitive abilities to understand the verbal instructions for the test according to the investigator's judgment
- absence of botulinum toxin injections within the last 3 months prior to enrolment
Exclusion Criteria:
- botulinum toxin injections within the last 3 months prior to enrolment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coefficient of ANtagonist activation
Time Frame: 5 seconds
|
The Coefficient of ANtagonist activation of 3 muscles was calculated by the ratio between the root mean square amplitude during antagonist effort and maximal agonist effort for the same muscle.
|
5 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Emilie Hutin, Hôpitaux Universitaires Henri Mondor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 19, 2023
First Posted (Actual)
October 25, 2023
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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