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
  Purpose

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 Intervention
Stroke
Other: Gait analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 9, 2010
Last Updated: March 3, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hemiplegia
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014