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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Gait analysis

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing of heel strike (s)	The goal is to use the data generated by this observational study to predict the timing of the heel strike when a patient walks.	10 seconds

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jérôme Froger, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimated): December 10, 2010

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Diagnostic Techniques and Procedures; Diagnosis; Population Characteristics; Physical Examination; Health; Physical Fitness; Gait; Physical Functional Performance; Gait Analysis
• Other Study ID Numbers: LOCAL/2009/JF-01; 2010-A00534-35 (Other Identifier: RCB number)