- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107556
Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury (NEUROGAIT)
October 24, 2023 updated by: Emilie Hutin, Henri Mondor University Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emilie Hutin, Ph.D.
- Phone Number: 0149812549
- Email: emilie.hutin@aphp.fr
Study Contact Backup
- Name: Emilie Hutin
- Phone Number: 0149812549
- Email: emilie.hutin@aphp.fr
Study Locations
-
-
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Créteil, France
- Laboratoire Analyse et Restauration du Mouvement
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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 a history of stroke
Description
Inclusion Criteria:
- Adult
- Person who performed tridimensional gait analysis in laboratory
- Person who had a stroke at least 6 months before the gait analysis
Exclusion Criteria:
- Any other neurological pathology or gait disorders
- Botulinum toxin injection in the last 3 months before the gait analysis
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: 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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 (Estimated)
October 19, 2023
Primary Completion (Estimated)
October 19, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A02258-37
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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