Cognitive-Frailty Gait Biomechanics for Early Dementia Detection (gait dementia)

February 26, 2026 updated by: Shazlin Shaharudin, Universiti Sains Malaysia

The purpose of this study is to better understand how physical characteristics, walking patterns, and a blood-based brain health marker differ between older adults with dementia and healthy older adults.

Dementia is often associated with changes in physical health and movement, but these changes are not fully understood. This study asks whether people with dementia show differences in body composition, walking ability, and levels of brain-derived neurotrophic factor (BDNF), a protein involved in brain function, compared with individuals without dementia.

To answer this question, participants will complete a single assessment session that includes basic physical measurements, an assessment of walking while moving at a comfortable pace, and a small blood sample collection. The information collected will be used to compare the two groups and explore possible relationships between physical function, walking patterns, and BDNF levels.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This observational, cross-sectional comparative study is designed to characterize differences in physical measurements, gait parameters, and circulating brain-derived neurotrophic factor (BDNF) levels between individuals with dementia and cognitively healthy older adults.

All data will be collected during a single study visit using standardized procedures. Physical and physiological measurements will be obtained following established protocols to ensure consistency across participants. Gait data will be captured using two-dimensional video-based motion capture and analyzed using validated software to extract spatiotemporal gait parameters. Calibration procedures will be performed prior to data collection to ensure measurement accuracy.

Venous blood samples will be collected by trained personnel and processed according to laboratory standard operating procedures to obtain plasma and serum. Samples will be stored and analyzed under controlled conditions using standardized assays for the quantification of BDNF.

Data quality will be ensured through predefined data entry procedures, range and consistency checks, and verification of source data against original measurement records. All collected data will be anonymized and stored in a secure database accessible only to authorized study personnel. Any missing or incomplete data will be documented, and analyses will be conducted using appropriate statistical methods to account for missing values.

The sample size is determined based on feasibility and prior literature involving similar observational comparisons. Statistical analyses will focus on descriptive and inferential comparisons between study groups, using appropriate parametric or non-parametric methods depending on data distribution. Multivariable analyses may be performed to account for relevant covariates. Statistical significance will be assessed using a predefined alpha level.

No study interventions will be administered, and participants will not undergo longitudinal follow-up.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shazlin Shaharudin, PhD
  • Phone Number: +609-767 7578
  • Email: shazlin@usm.my

Study Locations

  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • School of Health Sciences
        • Contact:
          • Asrenee Ab Razak, MD, PhD
          • Phone Number: +609-7676004
          • Email: asrenee@usm.my

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

USM memory clinic

Description

Inclusion Criteria:

  • Older adults aged 50 years and above
  • Able to ambulate independently without the use of walking aids
  • Must be able to understand instructions, communicate effectively
  • Free from any acute or unstable medical conditions at the time of assessment.

Healthy older adults group:

-No history or symptoms of cognitive impairments and have normal cognitive screening results.

Mild Cognitive Impairment (MCI) group:

-Must fulfill established diagnostic criteria for MCI, showing measurable cognitive decline without significant functional impairment and without a diagnosis of dementia.

Exclusion Criteria:

  • Present with any diagnosed neurological disorder such as stroke or Parkinson's disease
  • History of psychiatric illness, including major depressive disorder.
  • Individuals with uncontrolled cardiovascular, metabolic, or endocrine conditions
  • Have significant visual, auditory, or musculoskeletal impairments that may influence gait performance
  • Currently taking medications known to affect cognitive or motor function
  • Unable to provide written informed consent

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

Cohorts and Interventions

Group / Cohort
MCI group
Older adults diagnosed with mild cognitive impairment (cases)
Healthy control group
Cognitively healthy older adults without MCI (controls)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed during normal walking
Time Frame: At baseline (single assessment)

Average gait speed measured during normal walking using motion capture analysis.

Unit of Measure:

Meters per second (m/s)
At baseline (single assessment)
Stride length during normal walking
Time Frame: At baseline

Mean stride length measured during normal walking using motion capture analysis.

Unit of Measure:

Meters (m)
At baseline
Cadence during normal walking
Time Frame: At baseline (single assessment)

Cadence measured during normal walking using motion capture analysis.

Unit of Measure:

Steps per minute (steps/min)
At baseline (single assessment)
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline (single assessment)

Global cognitive function measured using the Montreal Cognitive Assessment (MoCA), a standardized cognitive screening tool assessing multiple cognitive domains.

Unit of Measure:

Score on a scale

Scale Description:

Montreal Cognitive Assessment (MoCA) total score ranges from 0 to 30, with higher scores indicating better cognitive function.
At baseline (single assessment)
Cognitive function assessed by the Mini-Mental State Examination (MMSE)
Time Frame: At baseline (single assessment)

Global cognitive function measured using the Mini-Mental State Examination (MMSE), a standardized cognitive screening instrument.

Unit of Measure:

Score on a scale

Scale Description:

Mini-Mental State Examination (MMSE) total score ranges from 0 to 30, with higher scores indicating better cognitive function.
At baseline (single assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: At baseline

Maximum handgrip strength measured using a handheld dynamometer.

Unit of Measure:

Kilograms (kg)
At baseline
Serum brain-derived neurotrophic factor (BDNF) concentration
Time Frame: At baseline

Serum brain-derived neurotrophic factor (BDNF) concentration measured from blood samples.

Unit of Measure:

ng/mL
At baseline
Functional mobility assessed by the Timed Up and Go test
Time Frame: At baseline (single assessment)

Functional mobility measured using the Timed Up and Go (TUG) test, which assesses the time required to stand up from a chair, walk 3 meters, turn, return, and sit down.

Unit of Measure:

Seconds (s)

Directionality:

Lower values indicate better functional mobility.
At baseline (single assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Shazlin Shaharudin, Universiti Sains Malaysia

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 (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/KK/24080690
  • FRGS/1/2024/SKK05/USM/02/2 (Other Grant/Funding Number: Ministry of Higher Education Malaysia)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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