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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06099132
Other study ID # CC2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2017

Study information

Verified date October 2023
Source Henri Mondor University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Electromyographic measurements
HD and bipolar EMG were assessed from gastrocnemius medialis (GM), soleus (SO) and tibialis anterior (TA) at seated position, ankle at 0°, during isometric submaximal effort and maximal effort, knee flexed (90°) and knee extended (0°)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Henri Mondor University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Coefficient of ANtagonist activation 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
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