Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults

NCT07739056 | Not Yet Recruiting DMC

• 1 other identifier: USharjah2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Accidental Falls/Prevention & Control

Keywords

Fall risk; Older adults; Balance; Neural control; Cognitive-motor integration; Phenotype-guided therapy

Outcome Measures

Primary Outcomes (6)

• 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

  From initiation of recruitment until enrollment of the final participant, anticipated period of (12 months)

• 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 (%)

  From enrollment through the 3-6-month follow-up.

• 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 (%)

  Throughout the 8-12-week intervention period.

• 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

  Immediately after completion of the 8-12-week intervention.

• Proportion of Participants with Usable Neurophysiological Data

  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 (%)

  Baseline and immediately after completion of the 8-12-week intervention

• Proportion of Participants with Complete Biomechanical Data

  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 (%)

  Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.

Secondary Outcomes (10)

• 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.

Study Arms (4)

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

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.

Other: Personalized Neurophysiological Rehabilitation

Phase 2: Randomized Controlled Trial (Intervention)/Conventional Fall-Prevention Exercise Program

ACTIVE COMPARATOR

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.

Other: Conventional Fall-Prevention Exercise Program

Interventions

Personalized Neurophysiological Rehabilitation OTHER

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) / Personalized Neurophysiological Rehabilitation

Conventional Fall-Prevention Exercise Program OTHER

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

Phase 2: Randomized Controlled Trial (Intervention)/Conventional Fall-Prevention Exercise Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

Location

Study Officials

• Ibrahim Moustafa Abuamer, professor

  University of Sharjah

  STUDY DIRECTOR

Central Study Contacts

Aisha Salim Alsuwaidi, PhD

CONTACT

+971507373053; U25100059@sharjah.ac.ae

Ibrahim Mostafa Abuamr, Professor

CONTACT

+972565057513; iabuamr@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principial investigator - Physiotherapy Department

Model Details: Phase 1 (Causal-Comparative Objective) To compare neural, neurocognitive, and biomechanical determinants of fall risk between older adults classified as high fall risk and those classified as low/no fall risk, using integrated multimodal measures including corticomuscular coherence (CMC), intermuscular coherence (IMC), prefrontal cerebral oxygenation (fNIRS), dual-task performance, and dynamic gait and balance parameters. Phase 2 (Randomized Controlled Trial Objective) To evaluate whether personalized rehabilitation guided by individual neurophysiological and neurocognitive profiles results in superior improvements compared with conventional non-stratified rehabilitation in: * Fall risk (primary clinical outcome) * Neural control efficiency * Cognitive-motor integration * Biomechanical stability and functional mobility

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)