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Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation (MASEA)

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ClinicalTrials.gov Identifier: NCT01257646
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
The main objective of this study is the estimation and comparison of the dephasing between the switch heel and the inertial placed on the paretic foot compared to the events of the gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in conditions without stimulation.

Condition or disease Intervention/treatment
Stroke Other: Gait analysis

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation
Study Start Date : May 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Recent stroke group
These patients have hemiplegia following a stroke within the last 6 months
Other: Gait analysis
A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.

Old stroke group
The patients have hemiplegia following a stroke that took place at least a year ago
Other: Gait analysis
A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.




Primary Outcome Measures :
  1. Timing of heel strike (s) [ Time Frame: 10 seconds ]
    The goal is to use the data generated by this observational study to predict the timing of the heel strike when a patient walks.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study patients are recuted from the patient pool that is either hospitalized or consulting in the department of Neurological Reeducation and Readaptation at the Grau du Roi medical center at the Nîmes University Hospital (Centre Hospitalier Universitaire de Nîmes). Patients are stroke victims with gait problems.
Criteria

Inclusion Criteria:

  • patient has had a first ischemic or hemorragic stroke (supratentorial) within the last 6 months for the "recent stroke" group, or more than a year ago for the "old stroke" group
  • the patient can walk 10 m without human help, with or without a cane, and a deficit of the foot levator requiring the use of technical assistance to remedy this or involving walking problems
  • electrostimulated contraction of the anterior tibialis is possible
  • patient has been informed and has signed the consent form

Exclusion Criteria:

  • cognitive disorder making participation in the study difficult
  • fixed plantar flexion, knee extended below 0°
  • patient refuses to sign consent
  • patient is not covered by a social security system
  • patient is under any kind of guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257646


Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jérôme Froger, MD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01257646     History of Changes
Other Study ID Numbers: LOCAL/2009/JF-01
2010-A00534-35 ( Other Identifier: RCB number )
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms