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Gait Parameters Analysis in Post-stroke Patients and in Elderly Fallers (GAITRITE)

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ClinicalTrials.gov Identifier: NCT01443052
Recruitment Status : Unknown
Verified April 2014 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 29, 2011
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
A large proportion of falls in older people occurs when walking. Most studies have recently demonstrated correlation between the variations in spatiotemporal gait parameters and fall risk in elderly and in several diseases. The investigators objective is to analyse this parameters in population with gait stability disorders (post-stroke patients and fallers) to identify the most valuable and to develop/test a conglomerate stability score.

Condition or disease Intervention/treatment
Healthy Thalamic Pain Syndrome Fallers Other: Gait analysis

Detailed Description:
Temporal-spatial gait parameters will be recorded in subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke, and 30 fallers while walking on an electronic walkway GAITRite® at self-selected speed.

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of the Temporospatial Gait Parameters With the Electronic Carpet "GAITRite" in Patients With Walking Impairment After Stroke and in Old Faller Subjects
Study Start Date : November 2010
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Group/Cohort Intervention/treatment
post-stroke patients
Stroke patients who had only one cerebrovascular accident, at least one year before inclusion and Able to walk without using assisting devices or ambulatory aids
Other: Gait analysis
walking on an electronic walkway GAITRite® at self-selected speed
healthy subjects
Aged 65 to 80 years
Other: Gait analysis
walking on an electronic walkway GAITRite® at self-selected speed
fallers
Reported 2 or more falls within 6 months prior to the beginning of the study and Able to walk without using assisting devices or ambulatory aids
Other: Gait analysis
walking on an electronic walkway GAITRite® at self-selected speed



Primary Outcome Measures :
  1. GAIT parameters [ Time Frame: at inclusion ]
    Spatiotemporal gait parameters registered by a GAITRite walkway system, including mean and coefficient of variation for step and cycle length and time, base of support, speed, cadence, single and double support phase, stance and swing phase.


Secondary Outcome Measures :
  1. Functional Ambulation Performance Score [ Time Frame: at inclusion ]
    a score which represents a quantification of patients' gait based on a selection of spatiotemporal parameters obtained at a self-selected speed.

  2. Rivermead Motricity Index [ Time Frame: at inclusion ]
    For post-stroke patients

  3. Berg Balance Scale [ Time Frame: at inclusion ]
    For post-stroke patients



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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke, and 30 fallers
Criteria
  1. For healthy subjects

    • Aged 65 to 80 years (included) ;
    • Patient has been informed and has signed the consent form.
  2. For post-stroke patients

    • Aged 65 to 80 years (included) ;
    • Stroke patients who had only one cerebrovascular accident, at least one year before inclusion ;
    • Able to walk without using assisting devices or ambulatory aids ;
    • No cardiovascular contraindication ;
    • No history of neurological diseases with influence on walking capacities (excepted stroke) ;
    • No history of vestibular or orthopaedic (lower limb) disorders ;
    • No amblyopia ;
    • Patient has been informed and has signed the consent form.
  3. For fallers

    • Aged 65 to 80 years (included) ;
    • Reported 2 or more falls within 6 months prior to the beginning of the study ;
    • Able to walk without using assisting devices or ambulatory aids ;
    • No cardiovascular contraindication ;
    • No history of neurological diseases with influence on walking capacities ;
    • No history of vestibular or orthopaedic (lower limb) disorders ;
    • No amblyopia ;
    • Patient has been informed and has signed the consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443052


Contacts
Contact: Alain Yelnik, PhD, MD alain.yelnik@lrb.aphp.fr
Contact: Arnaud Gouelle arnaud.gouelle@orange.fr

Locations
France
PRM Department - Lariboisiere Hospital Recruiting
Paris, France, 75010
Contact: Arnaud Gouelle    +33(0) 1 40 03 20 00 (12 90)    arnaud.gouelle@orange.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alain Yelnik PRM department

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01443052     History of Changes
Other Study ID Numbers: UC1002
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Gait stability
Spatiotemporal parameters
Walking
Elderly people
Stroke
Fallers