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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01443052
First received: May 4, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention
Healthy
Thalamic Pain Syndrome
Fallers
Other: Gait analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • GAIT parameters [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    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:
  • Functional Ambulation Performance Score [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    a score which represents a quantification of patients' gait based on a selection of spatiotemporal parameters obtained at a self-selected speed.

  • Rivermead Motricity Index [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    For post-stroke patients

  • Berg Balance Scale [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    For post-stroke patients


Estimated Enrollment: 90
Study Start Date: November 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: Gait analysis
healthy subjects
Aged 65 to 80 years
Other: Gait analysis
walking on an electronic walkway GAITRite® at self-selected speed
Other Name: Gait analysis
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01443052     History of Changes
Other Study ID Numbers: UC1002
Study First Received: May 4, 2011
Last Updated: April 11, 2014
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Thalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014