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

NCT01257646 | Completed

• 2 other identifiers: LOCAL/2009/JF-012010-A00534-35
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Recent stroke group

EXPERIMENTAL

These patients have hemiplegia following a stroke within the last 6 months

Other: Gait analysis

Old stroke group

ACTIVE COMPARATOR

The patients have hemiplegia following a stroke that took place at least a year ago

Other: Gait analysis

Interventions

Gait analysis OTHER

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

Old stroke group; Recent stroke group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Jérôme Froger, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: May 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 18, 2025

Record last verified: 2015-03

Locations

FR (1)