DementiaNCT06713070
Role of Gait Analysis in Different Type of Dementia
An observational study of Dementia and Gait Analysis, run by Assiut University at 1 site in Egypt.
Trial summary
Aim for the work is the studying of the existence and pattern of gait impairment in pre-dementia and dementia To examine the association between dual decline in gait and cognition Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Gait Analysis
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2024to 10 Jan 2026
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 30 to 80 yrs old diagnosed with pre-dementia and/or dementia according to the Vascular Behavior and Cognitive Disorder (VASCOG) who are able to perform gait analysis tests
Who may be able to join
- Patients aged 30-80 years. Patients with pre-dementia or dementia diagnosed according to VASCOG criteria. Ability to walk independently and perform gait assessment.
Who cannot join
- History of clinically manifest cerebrovascular stroke. Definite lateralizing neurological signs. Severe cognitive impairment (MoCA score of 4). Spinal or orthopedic problems affecting gait. Long-term use or abuse of medications affecting cognition or balance. Clinical evidence of peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern of Gait Abnormality as a Predictor for Disease Progression in Dementia
Aim for the work is the studying of the existence and pattern of gait impairment in pre-dementia and dementia To examine the association between dual decline in gait and cognition
Read the detailed description
Dementia is a syndrome usually chronic,characterised by progressive global deterioration in intellect, including memory,learning,orientation,comprehension,judgment,gait, and balance
Gait and balance are the product of successful integration of various posture control mechanisms and locomotion.
There are two basic phases in the full cycle of the step Stance phase Swing phase Slow gait speeds are associated with both cognitive decline and greater risk of dementia So, our aim of this work is to study the existence and pattern of gait balance impairment in patients with different types of dementia and comparison with healthy elderly people.
- Conditions
- Dementia, Gait Analysis
- Keywords
- Dementia, Gait analysis, Prognosis
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Dementia) | The group that will contain the diseased participants (Dementic patients able to walk and perform gait analysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
-Comparison of gait speed (m/s), measured using PODOSmart® instrumented insoles, between patients with dementia and healthy controls.
Measured: Baseline assessment.
Gait Symmetry
Comparison of gait symmetry (%), measured using PODOSmart® instrumented insoles, between patients with dementia and healthy controls.
Measured: Baseline assessment.
Secondary outcomes (7)
Berg Balance Scale
Comparison of Berg Balance Scale scores (0-56) between dementia patients and healthy controls.
Measured: Baseline assessment
Dynamic Gait Index
Comparison of Dynamic Gait Index scores (0-24) between the two groups.
Measured: Baseline assessment
Timed Up and Go Test .
Comparison of completion time (seconds) between the two groups.
Measured: Baseline assessment
Timed 25-Foot Walk Test
Comparison of walking time (seconds) between the two groups.
Measured: Baseline assessment
Stride Length
Comparison of stride length (cm), measured using PODOSmart®.
Measured: Baseline assessment
Cadence
Comparison of cadence (steps/min), measured using PODOSmart®.
Measured: Baseline assessment
Stride Duration
Comparison of stride duration (seconds), measured using PODOSmart®.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start12 Dec 2024
- Primary completion15 Nov 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Samwaeil Attia Salib, Assiut University
- Investigators
- Anwer M Ali, Professor, Study director, Department of Neuropsychiatry in Assuit University Tertiary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713070
- Sponsor's protocol ID
- Gait analysis in dementia
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.
PubMed 32738937Jack CR Jr, Knopman DS, Jagust WJ, Petersen RC, Weiner MW, Aisen PS, Shaw LM, Vemuri P, Wiste HJ, Weigand SD, Lesnick TG, Pankratz VS, Donohue MC, Trojanowski JQ. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013 Feb;12(2):207-16. doi: 10.1016/S1474-4422(12)70291-0.
PubMed 23332364Borson S, Raskind MA. Clinical features and pharmacologic treatment of behavioral symptoms of Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 6):S17-24. doi: 10.1212/wnl.48.5_suppl_6.17s.
PubMed 9153156Rodriguez Garcia PL, Rodriguez Garcia D. Diagnosis of vascular cognitive impairment and its main categories. Neurologia. 2015 May;30(4):223-39. doi: 10.1016/j.nrl.2011.12.014. Epub 2012 Jun 26. English, Spanish.
PubMed 22739039Dicharry J. Kinematics and kinetics of gait: from lab to clinic. Clin Sports Med. 2010 Jul;29(3):347-64. doi: 10.1016/j.csm.2010.03.013.
PubMed 20610026Jayakody O, Breslin M, Srikanth VK, Callisaya ML. Gait Characteristics and Cognitive Decline: A Longitudinal Population-Based Study. J Alzheimers Dis. 2019;71(s1):S5-S14. doi: 10.3233/JAD-181157.
PubMed 30958358Verghese J, Wang C, Lipton RB, Holtzer R, Xue X. Quantitative gait dysfunction and risk of cognitive decline and dementia. J Neurol Neurosurg Psychiatry. 2007 Sep;78(9):929-35. doi: 10.1136/jnnp.2006.106914. Epub 2007 Jan 19.
PubMed 17237140Moran C, Beare R, Phan TG, Bruce DG, Callisaya ML, Srikanth V; Alzheimer's Disease Neuroimaging Initiative (ADNI). Type 2 diabetes mellitus and biomarkers of neurodegeneration. Neurology. 2015 Sep 29;85(13):1123-30. doi: 10.1212/WNL.0000000000001982. Epub 2015 Sep 2.
PubMed 26333802Brach JS, Talkowski JB, Strotmeyer ES, Newman AB. Diabetes mellitus and gait dysfunction: possible explanatory factors. Phys Ther. 2008 Nov;88(11):1365-74. doi: 10.2522/ptj.20080016. Epub 2008 Sep 18.
PubMed 18801861Blumen HM, Brown LL, Habeck C, Allali G, Ayers E, Beauchet O, Callisaya M, Lipton RB, Mathuranath PS, Phan TG, Pradeep Kumar VG, Srikanth V, Verghese J. Gray matter volume covariance patterns associated with gait speed in older adults: a multi-cohort MRI study. Brain Imaging Behav. 2019 Apr;13(2):446-460. doi: 10.1007/s11682-018-9871-7.
PubMed 29629501Jayakody O, Breslin M, Beare R, Srikanth VK, Blumen HM, Callisaya ML. The Associations Between Grey Matter Volume Covariance Patterns and Gait Variability-The Tasmanian Study of Cognition and Gait. Brain Topogr. 2021 Jul;34(4):478-488. doi: 10.1007/s10548-021-00841-5. Epub 2021 Apr 29.
PubMed 33914190Rosano C, Studenski SA, Aizenstein HJ, Boudreau RM, Longstreth WT Jr, Newman AB. Slower gait, slower information processing and smaller prefrontal area in older adults. Age Ageing. 2012 Jan;41(1):58-64. doi: 10.1093/ageing/afr113. Epub 2011 Sep 28.
PubMed 21965414Srikanth V, Beare R, Blizzard L, Phan T, Stapleton J, Chen J, Callisaya M, Martin K, Reutens D. Cerebral white matter lesions, gait, and the risk of incident falls: a prospective population-based study. Stroke. 2009 Jan;40(1):175-80. doi: 10.1161/STROKEAHA.108.524355. Epub 2008 Oct 16.
PubMed 18927448Del Campo N, Payoux P, Djilali A, Delrieu J, Hoogendijk EO, Rolland Y, Cesari M, Weiner MW, Andrieu S, Vellas B; MAPT/DSA Study Group. Relationship of regional brain beta-amyloid to gait speed. Neurology. 2016 Jan 5;86(1):36-43. doi: 10.1212/WNL.0000000000002235. Epub 2015 Dec 7.
PubMed 26643548Dias EN, da Silva JV, Pais-Ribeiro JL, Martins T. Validation of the advanced activities of daily living scale. Geriatr Nurs. 2019 Jan-Feb;40(1):7-12. doi: 10.1016/j.gerinurse.2018.05.008. Epub 2018 Jun 13.
PubMed 29909023
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Gait Abnormality as a Predictor for Disease Progression in Dementia
- ClinicalTrials.gov ID
- NCT06713070
- Acronym / sponsor ID
- Gait analysis in dementia
- Conditions
- Dementia, Gait Analysis
- Keywords
- Dementia, Gait analysis, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 3 Dec 2024 (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.
Aim for the work is the studying of the existence and pattern of gait impairment in pre-dementia and dementia To examine the association between dual decline in gait and cognition
Detailed description
Dementia is a syndrome usually chronic,characterised by progressive global deterioration in intellect, including memory,learning,orientation,comprehension,judgment,gait, and balance
Gait and balance are the product of successful integration of various posture control mechanisms and locomotion.
There are two basic phases in the full cycle of the step Stance phase Swing phase Slow gait speeds are associated with both cognitive decline and greater risk of dementia So, our aim of this work is to study the existence and pattern of gait balance impairment in patients with different types of dementia and comparison with healthy elderly people.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Dementia) | – | –The group that will contain the diseased participants (Dementic patients able to walk and perform gait analysis) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 30 to 80 yrs old diagnosed with pre-dementia and/or dementia according to the Vascular Behavior and Cognitive Disorder (VASCOG) who are able to perform gait analysis tests
Key inclusion criteria (1 listed)
- Patients aged 30-80 years. Patients with pre-dementia or dementia diagnosed according to VASCOG criteria. Ability to walk independently and perform gait assessment.
Key exclusion criteria (1 listed)
- History of clinically manifest cerebrovascular stroke. Definite lateralizing neurological signs. Severe cognitive impairment (MoCA score of 4). Spinal or orthopedic problems affecting gait. Long-term use or abuse of medications affecting cognition or balance. Clinical evidence of peripheral neuropathy.
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
Gait Speed
Time frame: Baseline assessment.
-Comparison of gait speed (m/s), measured using PODOSmart® instrumented insoles, between patients with dementia and healthy controls.
Gait Symmetry
Time frame: Baseline assessment.
Comparison of gait symmetry (%), measured using PODOSmart® instrumented insoles, between patients with dementia and healthy controls.
7 secondary outcomes
Berg Balance Scale
Time frame: Baseline assessment
Dynamic Gait Index
Time frame: Baseline assessment
Timed Up and Go Test .
Time frame: Baseline assessment
Timed 25-Foot Walk Test
Time frame: Baseline assessment
Stride Length
Time frame: Baseline assessment
Cadence
Time frame: Baseline assessment
Stride Duration
Time frame: Baseline assessment
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 4 Nov 2026.
- Background: PubMed 32738937Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.
- Background: PubMed 23332364Jack CR Jr, Knopman DS, Jagust WJ, Petersen RC, Weiner MW, Aisen PS, Shaw LM, Vemuri P, Wiste HJ, Weigand SD, Lesnick TG, Pankratz VS, Donohue MC, Trojanowski JQ. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013 Feb;12(2):207-16. doi: 10.1016/S1474-4422(12)70291-0.
- Background: PubMed 9153156Borson S, Raskind MA. Clinical features and pharmacologic treatment of behavioral symptoms of Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 6):S17-24. doi: 10.1212/wnl.48.5_suppl_6.17s.
- Background: PubMed 22739039Rodriguez Garcia PL, Rodriguez Garcia D. Diagnosis of vascular cognitive impairment and its main categories. Neurologia. 2015 May;30(4):223-39. doi: 10.1016/j.nrl.2011.12.014. Epub 2012 Jun 26. English, Spanish.
- Background: PubMed 20610026Dicharry J. Kinematics and kinetics of gait: from lab to clinic. Clin Sports Med. 2010 Jul;29(3):347-64. doi: 10.1016/j.csm.2010.03.013.
- Background: PubMed 30958358Jayakody O, Breslin M, Srikanth VK, Callisaya ML. Gait Characteristics and Cognitive Decline: A Longitudinal Population-Based Study. J Alzheimers Dis. 2019;71(s1):S5-S14. doi: 10.3233/JAD-181157.
- Background: PubMed 17237140Verghese J, Wang C, Lipton RB, Holtzer R, Xue X. Quantitative gait dysfunction and risk of cognitive decline and dementia. J Neurol Neurosurg Psychiatry. 2007 Sep;78(9):929-35. doi: 10.1136/jnnp.2006.106914. Epub 2007 Jan 19.
- Background: PubMed 26333802Moran C, Beare R, Phan TG, Bruce DG, Callisaya ML, Srikanth V; Alzheimer's Disease Neuroimaging Initiative (ADNI). Type 2 diabetes mellitus and biomarkers of neurodegeneration. Neurology. 2015 Sep 29;85(13):1123-30. doi: 10.1212/WNL.0000000000001982. Epub 2015 Sep 2.
- Background: PubMed 18801861Brach JS, Talkowski JB, Strotmeyer ES, Newman AB. Diabetes mellitus and gait dysfunction: possible explanatory factors. Phys Ther. 2008 Nov;88(11):1365-74. doi: 10.2522/ptj.20080016. Epub 2008 Sep 18.
- Background: PubMed 29629501Blumen HM, Brown LL, Habeck C, Allali G, Ayers E, Beauchet O, Callisaya M, Lipton RB, Mathuranath PS, Phan TG, Pradeep Kumar VG, Srikanth V, Verghese J. Gray matter volume covariance patterns associated with gait speed in older adults: a multi-cohort MRI study. Brain Imaging Behav. 2019 Apr;13(2):446-460. doi: 10.1007/s11682-018-9871-7.
- Background: PubMed 33914190Jayakody O, Breslin M, Beare R, Srikanth VK, Blumen HM, Callisaya ML. The Associations Between Grey Matter Volume Covariance Patterns and Gait Variability-The Tasmanian Study of Cognition and Gait. Brain Topogr. 2021 Jul;34(4):478-488. doi: 10.1007/s10548-021-00841-5. Epub 2021 Apr 29.
- Background: PubMed 21965414Rosano C, Studenski SA, Aizenstein HJ, Boudreau RM, Longstreth WT Jr, Newman AB. Slower gait, slower information processing and smaller prefrontal area in older adults. Age Ageing. 2012 Jan;41(1):58-64. doi: 10.1093/ageing/afr113. Epub 2011 Sep 28.
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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.
Anwer M Ali, Professor study director
Department of Neuropsychiatry in Assuit University Tertiary Hospital
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 Dementia and Gait Analysis, run by Assiut University at 1 site in Egypt.
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 1 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 4 Nov 2026. 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 Egypt. 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 Speed (time frame: Baseline assessment.). The study lists 2 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 NCT06713070, which also lists 17 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 4 Nov 2026.