Cognitive-Frailty Gait Biomechanics for Early Dementia Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gait speed during normal walking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
MCI group
Older adults diagnosed with mild cognitive impairment (cases)
Healthy control group
Cognitively healthy older adults without MCI (controls)
结局指标
主要结局
Gait speed during normal walking
时间窗: At baseline (single assessment)
Average gait speed measured during normal walking using motion capture analysis. Unit of Measure: Meters per second (m/s)
Stride length during normal walking
时间窗: At baseline
Mean stride length measured during normal walking using motion capture analysis. Unit of Measure: Meters (m)
Cadence during normal walking
时间窗: At baseline (single assessment)
Cadence measured during normal walking using motion capture analysis. Unit of Measure: Steps per minute (steps/min)
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: 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.
Cognitive function assessed by the Mini-Mental State Examination (MMSE)
时间窗: 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.
次要结局
- Handgrip strength(At baseline)
- Serum brain-derived neurotrophic factor (BDNF) concentration(At baseline)
- Functional mobility assessed by the Timed Up and Go test(At baseline (single assessment))
研究者
Shazlin Shaharudin
Assoc Prof Ts Dr
Universiti Sains Malaysia