NCT06713070

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

June 2, 2024

Last Update Submit

November 30, 2024

Conditions

Keywords

DementiaGait analysisPrognosis

Outcome Measures

Primary Outcomes (1)

  • Analysis and comparison gait analysis in different types of dementia , pre dementia and elderly people

    \- The studying of the existence and pattern of gait impairment in pre-dementia and dementia and Role and important gait in prediction of disease progression by * The new smart insole PODOSmart®, a new tool for gait analysis recording the gait through sensors in foot tabs for 60 seconds and analysing the data. * Advanced athactivity of daily living scale (AADLs). * Berg balance test (BBT) . Other tools for gait analysis: Dynamic gait index and Figure 8 walk test So, this will study the association between dual decline in gait and cognition with the risk of dementia. And studying of relationship between gait impairment and Cognitive decline in Dementic patients ,which the greater cognitive decline,the greater gait impairment.

    Baseline

Study Arms (1)

Cohort 1 (Dementia)

The group that will contain the diseased participants (Dementic patients able to walk and perform gait analysis)

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • patients with pre-dementia,dementia, and dementia diagnosed according to The Vascular Behaviour and Cognitive Disorder (VASCOG) and on medication Criteria attending Assiut University neurology outpatient clinic and internal department

You may not qualify if:

  • history of clinic manfist cerebrovascular stroke 2 definitely laterization sign 3 severe cognitive imparment MOCA 4 Spinal or orthopaedic problems 5 long-term use or abuse of medication affect cognition or balance 6 clinical evidence of peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 32738937BACKGROUND
  • Jack 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.

    PMID: 23332364BACKGROUND
  • Borson 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.

    PMID: 9153156BACKGROUND
  • Rodriguez 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.

    PMID: 22739039BACKGROUND
  • Dicharry 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.

    PMID: 20610026BACKGROUND
  • Jayakody 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.

    PMID: 30958358BACKGROUND
  • Verghese 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.

    PMID: 17237140BACKGROUND
  • Moran 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.

    PMID: 26333802BACKGROUND
  • Brach 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.

    PMID: 18801861BACKGROUND
  • Blumen 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.

    PMID: 29629501BACKGROUND
  • Jayakody 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.

    PMID: 33914190BACKGROUND
  • Rosano 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.

    PMID: 21965414BACKGROUND
  • Srikanth 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.

    PMID: 18927448BACKGROUND
  • Del 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.

    PMID: 26643548BACKGROUND
  • Dias 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.

    PMID: 29909023BACKGROUND
  • Rahman TT, El Gaafary MM. Montreal Cognitive Assessment Arabic version: reliability and validity prevalence of mild cognitive impairment among elderly attending geriatric clubs in Cairo. Geriatr Gerontol Int. 2009 Mar;9(1):54-61. doi: 10.1111/j.1447-0594.2008.00509.x.

    PMID: 19260980BACKGROUND
  • Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

    PMID: 1468055BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Anwer M Ali, Professor

    Department of Neuropsychiatry in Assuit University Tertiary Hospital

    STUDY DIRECTOR

Central Study Contacts

Hanan S Attia, Resident

CONTACT

Anwer M Ali, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

June 2, 2024

First Posted

December 3, 2024

Study Start

December 1, 2024

Primary Completion

May 1, 2025

Study Completion

October 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share