Clinical trial NCT01443052: Gait Parameters Analysis in Post-stroke Patients and in Elderly Fallers
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Thalamic Pain Syndrome
Fallers
Keywords: Gait stability
Spatiotemporal parameters
Walking
Elderly people
Stroke
Fallers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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.

Primary outcomes:
measure: GAIT parameters
timeFrame: at inclusion
Secondary outcomes:
measure: Functional Ambulation Performance Score
timeFrame: at inclusion
measure: Rivermead Motricity Index
timeFrame: at inclusion
measure: Berg Balance Scale
timeFrame: at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: PRM Department - Lariboisiere Hospital
Study officials:
affiliation: PRM department
name: Alain Yelnik
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.