- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443052
Gait Parameters Analysis in Post-stroke Patients and in Elderly Fallers (GAITRITE)
June 14, 2021 updated by: Assistance Publique - Hôpitaux de Paris
Study of the Temporospatial Gait Parameters With the Electronic Carpet "GAITRite" in Patients With Walking Impairment After Stroke and in Old Faller Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75010
- PRM Department - Lariboisiere Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
For healthy subjects
- Aged 65 to 80 years (included) ;
- Patient has been informed and has signed the consent form.
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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
walking on an electronic walkway GAITRite® at self-selected speed
|
|
healthy subjects
Aged 65 to 80 years
|
walking on an electronic walkway GAITRite® at self-selected speed
|
|
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
|
walking on an electronic walkway GAITRite® at self-selected speed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GAIT parameters
Time Frame: at inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Ambulation Performance Score
Time Frame: at inclusion
|
a score which represents a quantification of patients' gait based on a selection of spatiotemporal parameters obtained at a self-selected speed.
|
at inclusion
|
|
Rivermead Motricity Index
Time Frame: at inclusion
|
For post-stroke patients
|
at inclusion
|
|
Berg Balance Scale
Time Frame: at inclusion
|
For post-stroke patients
|
at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alain Yelnik, PRM department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2010
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
May 4, 2011
First Submitted That Met QC Criteria
September 28, 2011
First Posted (Estimate)
September 29, 2011
Study Record Updates
Last Update Posted (Actual)
June 15, 2021
Last Update Submitted That Met QC Criteria
June 14, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UC1002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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