HealthyGAITRITENCT01443052
Gait Parameters Analysis in Post-stroke Patients and in Elderly Fallers
An observational study of Healthy and Thalamic Pain Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Thalamic Pain Syndrome, Fallers
- What is being tested?
- Gait analysis
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke, and 30 fallers
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Thalamic Pain Syndrome, Fallers
- Being tested
- Gait analysis
- Keywords
- Gait stability, Spatiotemporal parameters, Walking, Elderly people, Stroke, Fallers
- Medical subject headings
- Thalamic Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
walking on an electronic walkway GAITRite® at self-selected speed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Gait analysis | |
| healthy subjects | Aged 65 to 80 years Receives: 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 Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
Secondary outcomes (3)
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.
Measured: at inclusion
Rivermead Motricity Index
For post-stroke patients
Measured: at inclusion
Berg Balance Scale
For post-stroke patients
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Yelnik, Principal investigator, PRM department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443052
- Sponsor's protocol ID
- UC1002
- Acronym
- GAITRITE
- Status last verified
- Jun 2021
- First submitted
- 4 May 2011
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11494184Hausdorff 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.
PubMed 11356774Bilney 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.
PubMed 12535728Menz 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.
PubMed 15196515Balasubramanian 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.
PubMed 19056272Gouelle 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.
PubMed 21298587
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01443052
- Acronym / sponsor ID
- GAITRITE / UC1002
- Conditions
- Healthy, Thalamic Pain Syndrome, Fallers
- Keywords
- Gait stability, Spatiotemporal parameters, Walking, Elderly people, Stroke, Fallers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| post-stroke patients | – | Other: Gait analysisStroke patients who had only one cerebrovascular accident, at least one year before inclusion and Able to walk without using assisting devices or ambulatory aids |
| healthy subjects | – | Other: Gait analysisAged 65 to 80 years |
| fallers | – | Other: Gait analysisReported 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 |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke, and 30 fallers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysiswalking on an electronic walkway GAITRite® at self-selected speed | Other | fallers, healthy subjects, post-stroke patients |
Primary outcome
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.
3 secondary outcomes
Functional Ambulation Performance Score
Time frame: at inclusion
Rivermead Motricity Index
Time frame: at inclusion
Berg Balance Scale
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Background: PubMed 11494184Hausdorff 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.
- Background: PubMed 11356774Hausdorff 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.
- Background: PubMed 12535728Bilney 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.
- Background: PubMed 15196515Menz 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.
- Background: PubMed 19056272Balasubramanian 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.
- Background: PubMed 21298587Gouelle 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.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Yelnik principal investigator
PRM department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Thalamic Pain Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAIT parameters (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443052, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.