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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06107556
Other study ID # 2023-A02258-37
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 19, 2023
Est. completion date June 30, 2024

Study information

Verified date October 2023
Source Henri Mondor University Hospital
Contact Emilie Hutin, Ph.D.
Phone 0149812549
Email emilie.hutin@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date October 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Gait analysis
3D gait analysis with electromyographic measurements

Locations

Country Name City State
France Laboratoire Analyse et Restauration du Mouvement Créteil

Sponsors (1)

Lead Sponsor Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
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