Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults: A Two-Phase Multimodal Investigation With a Phenotype-Guided Rehabilitation Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this clinical trial with an embedded observational phase is to evaluate whether a phenotype-guided, personalized rehabilitation program can improve fall risk and underlying neural control mechanisms in older adults aged ≥65 years, including both high and low fall-risk individuals.
The main questions it aims to answer are:
Do older adults at high fall risk exhibit altered neural, neurocognitive, and biomechanical profiles compared with low/no fall-risk individuals? Does personalized rehabilitation guided by neurophysiological and neurocognitive profiles result in greater reductions in fall risk and improvements in motor control compared with conventional rehabilitation?
Researchers will compare personalized phenotype-guided rehabilitation to conventional evidence-based fall-prevention exercise to determine whether targeted, mechanism-based intervention leads to superior clinical and mechanistic outcomes.
Participants will:
Undergo a comprehensive multimodal assessment including neurophysiological (EEG, EMG), neurocognitive (fNIRS, dual-task testing), and biomechanical (gait and balance) measures Be classified into fall-risk and neurophysiological control profiles based on assessment results (Phase 2 - high fall-risk participants only) be randomly assigned to either personalized rehabilitation or conventional rehabilitation Attend supervised exercise sessions 2-3 times per week for 8-12 weeks Complete gait, balance, and cognitive-motor assessments before and after the intervention Record falls prospectively using monthly fall diaries and follow-up monitoring over 3-6 months
详细描述
Background:
Falls among older adults are a leading cause of injury, disability, and loss of independence worldwide. Despite the availability of exercise-based and multifactorial interventions, their effectiveness remains inconsistent, partly because current approaches do not adequately address the underlying mechanisms of instability. Emerging evidence suggests that fall risk arises from complex interactions between neural, cognitive, and biomechanical systems, with substantial heterogeneity in control strategies across individuals. This study aims to develop and evaluate a mechanism-based framework that integrates these domains to improve fall-risk assessment and guide personalized rehabilitation.
Objectives:
The primary objectives are: (1) to compare neural, neurocognitive, and biomechanical determinants of fall risk between older adults with high and low fall risk; and (2) to evaluate whether a personalized rehabilitation program guided by individual neurophysiological and neurocognitive profiles leads to greater reductions in fall risk and improvements in motor control compared with conventional rehabilitation.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria:
- •Age ≥ 65 years
- •Community-dwelling
- •Ability to ambulate independently (with or without assistive device)
- •Ability to understand instructions and provide informed consent
- •Participants will be stratified into fall-risk categories based on established criteria:
- •High fall risk: history of ≥1 fall in the previous 12 months and/or impaired functional performance (e.g., TUG > 13.5 s or BBS ≤49)
- •Low/no fall risk: no falls and preserved functional mobility These criteria are consistent with previously published fall-prevention trials.
排除标准
- •Participants will be excluded if they have:
- •Neurological conditions affecting gait or balance (e.g., stroke, Parkinson's disease)
- •Severe musculoskeletal disorders limiting mobility
- •Severe cognitive impairment (e.g., inability to follow instructions or MoCA < 18)
- •Uncontrolled cardiovascular or metabolic conditions
- •Current participation in structured rehabilitation programs
- •Contraindications to EEG, EMG, or fNIRS measurements
结局指标
主要结局
Recruitment Rate
时间窗: From initiation of recruitment until enrollment of the final participant, anticipated period of (12 months)
Recruitment feasibility will be assessed by calculating the average number of participants enrolled per month during the recruitment period. Unit of Measure: Participants/month
Participant Attrition Rate
时间窗: From enrollment through the 3-6-month follow-up.
Participant retention will be assessed by calculating the proportion of enrolled participants who withdraw or are lost to follow-up before completion of the final study assessment. Unit of Measure: Percentage (%)
Supervised Intervention Attendance Rate
时间窗: Throughout the 8-12-week intervention period.
Intervention adherence will be assessed by calculating the percentage of prescribed supervised intervention sessions attended by each participant. Unit of Measure: Percentage (%)
Participant Satisfaction with the Intervention
时间窗: Immediately after completion of the 8-12-week intervention.
Acceptability of the intervention will be assessed using a participant satisfaction questionnaire ( PSQ-18) administered after completion of the intervention. The total satisfaction score will be reported, with higher scores indicating greater participant satisfaction. Unit of Measure: Questionnaire total score
Proportion of Participants with Usable Neurophysiological Data
时间窗: Baseline and immediately after completion of the 8-12-week intervention
Data quality will be assessed by calculating the proportion of participants with complete, artifact-free, and analyzable neurophysiological recordings (EEG, EMG, and fNIRS) according to predefined signal-quality criteria. Unit of Measure: Percentage (%)
Proportion of Participants with Complete Biomechanical Data
时间窗: Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.
Data completeness will be assessed by calculating the proportion of participants with complete and analyzable biomechanical recordings, including gait and balance measures, according to predefined quality-control criteria. Unit of Measure: Percentage (%)
次要结局
- Number of Falls per Participant(During the 3- to 6-month follow-up period after completion of the intervention.)
- Time to First Fall(During the 3- to 6-month follow-up period after completion of the intervention.)
- Neurophysiological Outcomes (Corticomuscular Coherence (CMC))(Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month)
- Neurophysiological Outcomes (Intermuscular Coherence (IMC))(Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month)
- Change in Prefrontal Oxygenated Hemoglobin Concentration During Dual-Task Walking(Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.)
- Functional Reach Test Distance(Baseline, post-intervention, and 3-6-month follow-up.)
- Change in Global Walk Quality Index(Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.)
- Change in Overall Balance Stability Index(Baseline, immediately after the 8-12-week intervention, and at the 3-6-month follow-up.)
- Timed Up and Go Test Completion Time(Baseline, post-intervention, and 3-6-month follow-up.)
- Berg Balance Scale Total Score(Baseline, post-intervention, and 3-6-month follow-up.)
研究者
Aisha Salim Alsuwaidi
principial investigator - Physiotherapy Department
University of Sharjah