NCT01443052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

4.7 years

First QC Date

May 4, 2011

Last Update Submit

June 14, 2021

Conditions

Keywords

Gait stabilitySpatiotemporal parametersWalkingElderly peopleStrokeFallers

Outcome Measures

Primary Outcomes (1)

  • GAIT parameters

    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.

    at inclusion

Secondary Outcomes (3)

  • Functional Ambulation Performance Score

    at inclusion

  • Rivermead Motricity Index

    at inclusion

  • Berg Balance Scale

    at inclusion

Study Arms (3)

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

healthy subjects

Aged 65 to 80 years

Other: 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

Interventions

walking on an electronic walkway GAITRite® at self-selected speed

fallershealthy subjectspost-stroke patients

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke, and 30 fallers

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

PRM Department - Lariboisiere Hospital

Paris, 75010, France

Location

Related Publications (6)

  • Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6. doi: 10.1053/apmr.2001.24893.

    PMID: 11494184BACKGROUND
  • Hausdorff JM, Nelson ME, Kaliton D, Layne JE, Bernstein MJ, Nuernberger A, Singh MA. Etiology and modification of gait instability in older adults: a randomized controlled trial of exercise. J Appl Physiol (1985). 2001 Jun;90(6):2117-29. doi: 10.1152/jappl.2001.90.6.2117.

    PMID: 11356774BACKGROUND
  • Bilney B, Morris M, Webster K. Concurrent related validity of the GAITRite walkway system for quantification of the spatial and temporal parameters of gait. Gait Posture. 2003 Feb;17(1):68-74. doi: 10.1016/s0966-6362(02)00053-x.

    PMID: 12535728BACKGROUND
  • Menz HB, Latt MD, Tiedemann A, Mun San Kwan M, Lord SR. Reliability of the GAITRite walkway system for the quantification of temporo-spatial parameters of gait in young and older people. Gait Posture. 2004 Aug;20(1):20-5. doi: 10.1016/S0966-6362(03)00068-7.

    PMID: 15196515BACKGROUND
  • Balasubramanian CK, Neptune RR, Kautz SA. Variability in spatiotemporal step characteristics and its relationship to walking performance post-stroke. Gait Posture. 2009 Apr;29(3):408-14. doi: 10.1016/j.gaitpost.2008.10.061. Epub 2008 Dec 3.

    PMID: 19056272BACKGROUND
  • Gouelle A, Megrot F, Presedo A, Pennecot GF, Yelnik A. Validity of Functional Ambulation Performance Score for the evaluation of spatiotemporal parameters of children's gait. J Mot Behav. 2011;43(2):95-100. doi: 10.1080/00222895.2010.538768.

    PMID: 21298587BACKGROUND

MeSH Terms

Conditions

Thalamic DiseasesStroke

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Alain Yelnik

    PRM department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2011

First Posted

September 29, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 15, 2021

Record last verified: 2021-06

Locations