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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01443052
Other study ID # UC1002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date July 2015

Study information

Verified date June 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gait analysis
walking on an electronic walkway GAITRite® at self-selected speed

Locations

Country Name City State
France PRM Department - Lariboisiere Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Functional Ambulation Performance Score a score which represents a quantification of patients' gait based on a selection of spatiotemporal parameters obtained at a self-selected speed. at inclusion
Secondary Rivermead Motricity Index For post-stroke patients at inclusion
Secondary Berg Balance Scale For post-stroke patients at inclusion
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