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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01257646
First received: December 9, 2010
Last updated: March 3, 2014
Last verified: March 2014

December 9, 2010
March 3, 2014
May 2011
July 2013   (final data collection date for primary outcome measure)
Timing of heel strike (s) [ Time Frame: 10 seconds ] [ Designated as safety issue: No ]
The goal is to use the data generated by this observational study to predict the timing of the heel strike when a patient walks.
Timing of heel strike (s) [ Time Frame: 10 seconds ] [ Designated as safety issue: No ]
Our goal is to use the data generated by this observational study to predict the timing of the heel strike when a patient walks.
Complete list of historical versions of study NCT01257646 on ClinicalTrials.gov Archive Site
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Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation
Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Stroke
Other: Gait analysis
A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.
  • Recent stroke group
    These patients have hemiplegia following a stroke within the last 6 months
    Intervention: Other: Gait analysis
  • Old stroke group
    The patients have hemiplegia following a stroke that took place at least a year ago
    Intervention: Other: Gait analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01257646
LOCAL/2009/JF-01, 2010-A00534-35
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Jérôme Froger, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP