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NCT07739056
Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults
Conditions: Accidental Falls/Prevention & Control
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 80
Sponsor: University of Sharjah
Location: University of Sharjah Sharjah city
Summary
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07739056). StuddyBuddy aggregates publicly available trial information.