StrokeCC2017NCT06099132
Antagonist Activation Measurement at the Ankle Using High-density and Bipolar Surface EMG in Chronic Hemiparesis
An observational study of Stroke and Muscle Hypertonia, run by Henri Mondor University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Muscle Hypertonia, Spasticity, Muscle
- What is being tested?
- Electromyographic measurements
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Person with chronic hemiparesis due to a non-evolutive central nervous system lesion
Who may be able to join
- 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
Who cannot join
- botulinum toxin injections within the last 3 months prior to enrolment
About this study
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.
Read the 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.
- Conditions
- Stroke, Muscle Hypertonia, Spasticity, Muscle
- Being tested
- Electromyographic measurements
- Medical subject headings
- Stroke, Muscle Hypertonia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic measurementsDiagnostic test
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°)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Hutin, Henri Mondor University Hospital
- Investigators
- Emilie Hutin, Study director, Hôpitaux Universitaires Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099132
- Sponsor's protocol ID
- CC2017
- Acronym
- CC2017
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonist Activation Measurement at the Ankle Using High-density and Bipolar Surface EMG in Chronic Hemiparesis
- ClinicalTrials.gov ID
- NCT06099132
- Acronym / sponsor ID
- CC2017 / CC2017
- Conditions
- Stroke, Muscle Hypertonia, Spasticity, Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Person with chronic hemiparesis due to a non-evolutive central nervous system lesion
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- botulinum toxin injections within the last 3 months prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyographic measurementsHD 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°) | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Hutin study director
Hôpitaux Universitaires Henri Mondor
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Muscle Hypertonia, run by Henri Mondor University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of ANtagonist activation (time frame: 5 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.