Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Sharjah
About this trial
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
This trial accepts healthy volunteersQualifiers
Age ≥ 65 years
Community-dwelling
Ability to ambulate independently (with or without assistive device)
Ability to understand instructions and provide informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized Neurophysiological Rehabilitation
Other interventionThe 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.
Conventional Fall-Prevention Exercise Program
Other interventionThe 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
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Phase 1: Observational / High Fall-Risk Older Adults - Multimodal AssessmentNo intervention 0 interventions
Group B: Phase 1: Observational / Low/No Fall-Risk Older Adults - Multimodal AssessmentNo intervention 0 interventions
Group C: Phase 2: Randomized Controlled Trial (Intervention) / Personalized Neurophysiological RehabilitationExperimental treatment 1 intervention
Group D: Phase 2: Randomized Controlled Trial (Intervention)/Conventional Fall-Prevention Exercise ProgramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Recruitment feasibility will be assessed by calculating the average number of participants enrolled per month during the recruitment period. Unit of Measure: Participants/month
Time frame
From initiation of recruitment until enrollment of the final participant, anticipated period of (12 months)2
Participant Attrition Rate
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 (%)
Time frame
From enrollment through the 3-6-month follow-up.3
Supervised Intervention Attendance Rate
Intervention adherence will be assessed by calculating the percentage of prescribed supervised intervention sessions attended by each participant. Unit of Measure: Percentage (%)
Time frame
Throughout the 8-12-week intervention period.4
Participant Satisfaction with the 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
Time frame
Immediately after completion of the 8-12-week intervention.Secondary outcomes
1
Number of Falls per Participant
Description The total number of falls experienced by each participant during the follow-up period will be prospectively recorded using monthly fall diaries, structured telephone follow-up, and caregiver confirmation when applicable. A fall is defined as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level." Unit of Measure Number of falls
Time frame
During the 3- to 6-month follow-up period after completion of the intervention.2
Time to First Fall
Time from completion of the intervention to the first prospectively recorded fall will be measured using monthly fall diaries, structured telephone follow-up, and caregiver confirmation when applicable. A fall is defined as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level." Unit of Measure Days (or Months, depending on your planned statistical analysis)
Time frame
During the 3- to 6-month follow-up period after completion of the intervention.3
Neurophysiological Outcomes (Corticomuscular Coherence (CMC))
Primary metric: ΔCMCβ = CMCFoam EC - CMCFirm EO Outcomes: * Change in ΔCMCβ from baseline to post-intervention * Normalization of task-dependent cortical modulation Interpretation: Reflects changes in cortical involvement and neural efficiency in postural control.
Time frame
Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month4
Neurophysiological Outcomes (Intermuscular Coherence (IMC))
Coordination of shared neural input between muscles assessed using intermuscular coherence. Primary metric: ΔIMCLF = IMCFoam EC - IMCFirm EO Outcomes: * Change in low-frequency IMC modulation * Improvement in coordination patterns Interpretation: Reflects reorganization of subcortical and intermuscular coordination mechanisms.
Time frame
Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 monthSponsors and contacts
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Source ClinicalTrials.gov
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