StrokeNEUROGAITNCT06107556
Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury
An observational study of Stroke and Walking, Difficulty, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Walking, Difficulty, Spasticity/Paresis
- What is being tested?
- Gait analysis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2023to 30 Jun 2024
- 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 a history of stroke
Who may be able to join
- Adult
- Person who performed tridimensional gait analysis in laboratory
- Person who had a stroke at least 6 months before the gait analysis
Who cannot join
- Any other neurological pathology or gait disorders
- Botulinum toxin injection in the last 3 months before the gait analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromechanical Characterization of Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury
The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment.
Read the detailed description
After injury to the central nervous system, walking disorders are associated with complex neuromuscular mechanisms that alter the direction and intensity of the descending control, reflex reactions to kinematic changes and the mechanical components of soft tissues. The dissociated analysis of these mechanisms and their interactions during multi-segmental movements and especially during walking is poorly described. However, a quantified assessment of the responsibility of each of the neuromuscular mechanisms in the functional disorder would guide the choice of treatments. 3D gait laboratories provide kinematic data from synchronized walking to surface electromyograms as part of additional assessments to assist in the follow-up of patients with chronic hemiparesis. Retrospective analysis of these data would help to better characterize muscular activation disorders and passive resistance to movement during walking in this population.
- Conditions
- Stroke, Walking, Difficulty, Spasticity/Paresis
- Being tested
- Gait analysis
- Medical subject headings
- Stroke, Mobility Limitation, Muscle Spasticity, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisDiagnostic test
3D gait analysis with electromyographic measurements
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 gastrocnemius medialis and soleus was calculated from EMG data by the ratio between the root mean square amplitude during antagonist effort and maximal agonist effort for the same muscle.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start19 Oct 2023 (estimated)
- Primary completion19 Oct 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
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
- Retrospective
- Enrolment
- 100 participants (estimated)
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, Principal investigator, Hôpitaux Universitaires Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107556
- Sponsor's protocol ID
- 2023-A02258-37
- Acronym
- NEUROGAIT
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 30 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromechanical Characterization of Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury
- ClinicalTrials.gov ID
- NCT06107556
- Acronym / sponsor ID
- NEUROGAIT / 2023-A02258-37
- Conditions
- Stroke, Walking, Difficulty, Spasticity/Paresis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2023 (estimated)
- Primary completion
- 19 Oct 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 30 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.
The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment.
Detailed description
After injury to the central nervous system, walking disorders are associated with complex neuromuscular mechanisms that alter the direction and intensity of the descending control, reflex reactions to kinematic changes and the mechanical components of soft tissues. The dissociated analysis of these mechanisms and their interactions during multi-segmental movements and especially during walking is poorly described. However, a quantified assessment of the responsibility of each of the neuromuscular mechanisms in the functional disorder would guide the choice of treatments. 3D gait laboratories provide kinematic data from synchronized walking to surface electromyograms as part of additional assessments to assist in the follow-up of patients with chronic hemiparesis. Retrospective analysis of these data would help to better characterize muscular activation disorders and passive resistance to movement during walking in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Person with a history of stroke
Key inclusion criteria (3 listed)
- Adult
- Person who performed tridimensional gait analysis in laboratory
- Person who had a stroke at least 6 months before the gait analysis
Key exclusion criteria (2 listed)
- Any other neurological pathology or gait disorders
- Botulinum toxin injection in the last 3 months before the gait analysis
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 |
|---|---|---|
| Gait analysis3D gait analysis with electromyographic measurements | Diagnostic test | – |
Primary outcome
Coefficient of antagonist activation
Time frame: 1 year
The coefficient of antagonist activation of gastrocnemius medialis and soleus was calculated from EMG data by the ratio between the root mean square amplitude during antagonist effort and maximal agonist effort for the same muscle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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 principal investigator
Hôpitaux Universitaires Henri Mondor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Walking, Difficulty, run by Henri Mondor University Hospital at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Hutin, Ph.D. (0149812549, emilie.hutin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of antagonist activation (time frame: 1 year). 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 30 Oct 2023.