NCT06099132

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

October 19, 2023

Last Update Submit

October 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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°)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Person with chronic hemiparesis due to a non-evolutive central nervous system lesion

You may qualify if:

  • 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

You may not qualify if:

  • botulinum toxin injections within the last 3 months prior to enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeMuscle HypertoniaMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Emilie Hutin

    Hôpitaux Universitaires Henri Mondor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 25, 2023

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share