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

Stroke Clinical Trial

— MASEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257646
• Other study ID #: LOCAL/2009/JF-01
• Secondary ID: 2010-A00534-35
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: March 24, 2015
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• Gait analysis
A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No