Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults: A Two-Phase Multimodal Investigation With a Phenotype-Guided Rehabilitation Trial
| Registry | NCT07739056 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 80 (Estimated) |
| Sponsor | University of Sharjah (Other) |
| Conditions | Accidental Falls/Prevention & Control |
| Interventions | Personalized Neurophysiological Rehabilitation, Conventional Fall-Prevention Exercise Program (Other) |
| Dates | start 2026-12-31 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-07-31, last updated 2026-07-31 |
| Locations | 1 site in United Arab Emirates |
Related Papers Related Patents Related Grants Related Experts
All trials for Accidental Falls/Prevention & Control All trials of Personalized Neurophysiological Rehabilitation All trials of Conventional Fall-Prevention Exercise Program
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
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:
This study adopts a two-phase multimodal design. Phase 1 is a cross-sectional causal-comparative study involving approximately 80 community-dwelling older adults aged 65 years and above, classified as high or low fall risk. Participants will undergo comprehensive assessment of neural control, neurocognitive load, and functional performance using electroencephalography and electromyography, functional near-infrared spectroscopy during dual-task conditions, and quantitative gait and balance analysis. Phase 2 is a pilot randomized controlled trial involving high fall-risk participants, who will be allocated to either a personalized rehabilitation program guided by individual neurophysiological and neurocognitive profiles or a conventional evidence-based fall-prevention program. Both groups will receive supervised training for 8-12 weeks. Primary outcomes include feasibility measures and prospective fall events over 3-6 months. Secondary outcomes include changes in neural control, cognitive-motor integration, and biomechanical stability.
Discussion:
This study proposes a novel phenotype-guided approach to fall prevention that targets the underlying neural control mechanisms rather than general physical impairments. By integrating multimodal assessments with personalized intervention, the study has the potential to improve the precision and effectiveness of rehabilitation strategies. Findings will provide important insights into the mechanisms of fall risk and inform the design of larger clinical trials and future clinical practice.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Phase 1: Observational / High Fall-Risk Older Adults - Multimodal Assessment | No intervention | Participants aged ≥65 years classified as high fall risk (based on fall history and/or impaired functional performance) will undergo a comprehensive multimodal assessment to characterize neural, neurocognitive, and biomechanical determinants of fall risk. No therapeutic intervention will be administered. Assessments include: Neurophysiological recordings using electroencephalography and electromyography during standardized balance tasks Neurocognitive assessment using functional near-infrared spectroscopy during single- and dual-task conditions Quantitative gait and balance assessment using wearable smartphone-based sensors Functional clinical measures of mobility and balance The purpose of this arm is to identify mechanistic differences and support neurophysiological phenotyping. | |
| Phase 1: Observational / Low/No Fall-Risk Older Adults - Multimodal Assessment | No intervention | Participants aged ≥65 years classified as low or no fall risk will undergo the same multimodal assessment protocol as the high-risk group. This arm serves as a reference group to establish normative ranges for neural, neurocognitive, and biomechanical variables Assessments include: * Neurophysiological recordings using electroencephalography and electromyography during standardized balance tasks * Neurocognitive assessment using functional near-infrared spectroscopy during single- and dual-task conditions * Quantitative gait and balance assessment using wearable smartphone-based sensors * Functional clinical measures of mobility and balance Data from this group will be used to define reference thresholds for neurophysiological classification and comparative analysis. | |
| Phase 2: Randomized Controlled Trial (Intervention) / Personalized Neurophysiological Rehabilitation | Experimental | Other: Personalized Neurophysiological Rehabilitation | Participants classified as high fall risk will receive a personalized rehabilitation program tailored to their individual neurophysiological and neurocognitive profile, derived from Phase 1 assessments. The intervention targets underlying neural control mechanisms and is adapted based on identified control strategies (e.g., cortical-dominant, reflex-dominant, or integrated control). Intervention components may include: Task-specific balance and gait training under variable sensory conditions Dual-task training to improve cognitive-motor integration External focus and rhythm-based training to enhance movement automaticity Reaction-based and perturbation training to improve adaptability Progressive modulation of task complexity based on participant response Program details: Duration: 8-12 weeks Frequency: 2-3 supervised sessions per week Session length: 45-60 minutes The intervention is dynamically progressed based on neurophysiological and functional responses. |
| Phase 2: Randomized Controlled Trial (Intervention)/Conventional Fall-Prevention Exercise Program | Active comparator | Other: Conventional Fall-Prevention Exercise Program | Participants classified as high fall risk will receive a standard evidence-based fall-prevention exercise program consistent with current clinical guidelines. The intervention focuses on general physical improvements rather than individualized neural mechanisms. Intervention components include: Balance training (static and dynamic postural control exercises) Lower-limb strengthening exercises (e.g., sit-to-stand, step-ups, resistance training) Gait and functional mobility training (walking, turning, obstacle negotiation) Flexibility and mobility exercises Education on fall prevention strategies Program details: Duration: 8-12 weeks Frequency: 2-3 supervised sessions per week Session length: 45-60 minutes Progression is based on standard clinical criteria such as safety, tolerance, and performance. |
Sex: All, ages: 65 Years to any, accepts healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Sharjah | Sharjah city | United Arab Emirates |