Gait ApraxiaCINERGYNCT04557592
Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs
An observational study of Gait Apraxia and Alzheimer Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient [ICC] > 95%) for spatial measures and against video-based (ICC > 93%) for temporal measures, and was thus a reliable tools to measure step… Read more about this study
- Who is it for?
- Ages 74 years and older
- Conditions the study is for
- Gait Apraxia, Alzheimer Disease, Impaired Cognition
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2019to 26 Feb 2020
- 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 74 years and older
- All sexes
- Older adult
Study population: All consecutive patients meeting the eligibility criteria over the study period.
Who may be able to join
- Age ≥ 75 years
- Gait analysis performed with the two walkways superimposed during a consultation or day hospitalization
Who cannot join
- Opposition to the use of the information collected for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient [ICC] > 95%) for spatial measures and against video-based (ICC > 93%) for temporal measures, and was thus a reliable tools to measure step lengths and times in both walkway center and left-of-center measurements. It was considered as one of the gold standards in gait analyses. This gait analyze system may distinguish prospectively faller and non-faller older adults, but it can detect spatial, temporal, and spatiotemporal measures of gait and greater variability of gait parameters which were associated with and predictive of both global- and domain-specific cognitive decline. Moreover, spatiotemporal gait parameters analyzed using GAITRite® were more disturbed in the advanced stages of dementia, and more affected in the non-AD dementia than in AD suggesting that quantitative gait parameters could be used as a surrogate marker for improving the diagnosis of dementia.
Nevertheless, GAITRite® is not a unique system and it comprises different walkways. One of these technologies was a roll-up system (platinum plus classic, RE, Basic and Safari), and the other was a system composed by a changeable association of plates (CIRFACE). In order to ensure a good comparability between studies using these different walkways, it appears important to compare the performances of these walkways in gait analysis. Thus, the main aim of this study was to compare the performances in gait analyze between the GAITRite® platinum plus classic and the GAITRite® CIRFACE among older adults. Secondary aims were to compare these parameters among patients with cognitive complaint, minor or major neurocognitive disorder (NCD) related to Alzheimer disease.
- Conditions
- Gait Apraxia, Alzheimer Disease, Impaired Cognition
- Medical subject headings
- Gait Apraxia, Alzheimer Disease, Cognition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices
in the sub-group: Absence of cognitive impairment
Measured: baseline
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices
in the sub-group: Minor Neurocognitive Disorder
Measured: baseline
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices
in the sub-group: Major Neurocognitive Disorder
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start17 Jun 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait ApraxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557592
- Sponsor's protocol ID
- 2020/110
- Acronym
- CINERGY
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sacco G, Ben-Sadoun G, Gautier J, Simon R, Goupil M, Laureau P, Terrien J, Annweiler C. Comparison of spatio-temporal gait parameters between the GAITRite(R) platinum plus classic and the GAITRite(R) CIRFACE among older adults: a retrospective observational study. BMC Geriatr. 2023 Mar 7;23(1):132. doi: 10.1186/s12877-023-03811-7.
PubMed 36882705
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs
- ClinicalTrials.gov ID
- NCT04557592
- Acronym / sponsor ID
- CINERGY / 2020/110
- Conditions
- Gait Apraxia, Alzheimer Disease, Impaired Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- 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.
The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient [ICC] > 95%) for spatial measures and against video-based (ICC > 93%) for temporal measures, and was thus a reliable tools to measure step lengths and times in both walkway center and left-of-center measurements. It was considered as one of the gold standards in gait analyses. This gait analyze system may distinguish prospectively faller and non-faller older adults, but it can detect spatial, temporal, and spatiotemporal measures of gait and greater variability of gait parameters which were associated with and predictive of both global- and domain-specific cognitive decline. Moreover, spatiotemporal gait parameters analyzed using GAITRite® were more disturbed in the advanced stages of dementia, and more affected in the non-AD dementia than in AD suggesting that quantitative gait parameters could be used as a surrogate marker for improving the diagnosis of dementia.
Nevertheless, GAITRite® is not a unique system and it comprises different walkways. One of these technologies was a roll-up system (platinum plus classic, RE, Basic and Safari), and the other was a system composed by a changeable association of plates (CIRFACE). In order to ensure a good comparability between studies using these different walkways, it appears important to compare the performances of these walkways in gait analysis. Thus, the main aim of this study was to compare the performances in gait analyze between the GAITRite® platinum plus classic and the GAITRite® CIRFACE among older adults. Secondary aims were to compare these parameters among patients with cognitive complaint, minor or major neurocognitive disorder (NCD) related to Alzheimer disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 74 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- All consecutive patients meeting the eligibility criteria over the study period.
Key inclusion criteria (2 listed)
- Age ≥ 75 years
- Gait analysis performed with the two walkways superimposed during a consultation or day hospitalization
Key exclusion criteria (1 listed)
- Opposition to the use of the information collected for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices
Time frame: baseline
in the sub-group: Absence of cognitive impairment
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices
Time frame: baseline
in the sub-group: Minor Neurocognitive Disorder
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices
Time frame: baseline
in the sub-group: Major Neurocognitive Disorder
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 21 Sep 2020.
- Derived from this study: PubMed 36882705Sacco G, Ben-Sadoun G, Gautier J, Simon R, Goupil M, Laureau P, Terrien J, Annweiler C. Comparison of spatio-temporal gait parameters between the GAITRite(R) platinum plus classic and the GAITRite(R) CIRFACE among older adults: a retrospective observational study. BMC Geriatr. 2023 Mar 7;23(1):132. doi: 10.1186/s12877-023-03811-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gait Apraxia and Alzheimer Disease, run by University Hospital, Angers 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 21 Sep 2020. 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?
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT04557592, which also lists 1 linked publication.
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 21 Sep 2020.