Healthy Clinical Trial
— GAITRITEOfficial title:
Study of the Temporospatial Gait Parameters With the Electronic Carpet "GAITRite" in Patients With Walking Impairment After Stroke and in Old Faller Subjects
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 |
Verified date | June 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | PRM Department - Lariboisiere Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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
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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