University of Sharjah
Sharjah city, United Arab Emirates
Location contact
Aisha S Alsuwaidi, PhD
PRINCIPAL_INVESTIGATOR
Ibrahim M Abuamr, professor
CONTACT
Not Yet Recruiting
NCT Number: NCT07739056
Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults
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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
65 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Personalized Neurophysiological Rehabilitation
OtherThe 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
OtherThe 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
Primary outcomes
-
Recruitment Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (%)
Secondary outcomes
-
Number of Falls per Participant
Time frame: During the 3- to 6-month follow-up period after completion of the intervention.
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 to First Fall
Time frame: During the 3- to 6-month follow-up period after completion of the intervention.
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)
-
Neurophysiological Outcomes (Corticomuscular Coherence (CMC))
Time frame: Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month
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.
-
Neurophysiological Outcomes (Intermuscular Coherence (IMC))
Time frame: Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month
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.
-
Change in Prefrontal Oxygenated Hemoglobin Concentration During Dual-Task Walking
Time frame: Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.
Prefrontal cortical activation will be assessed using functional near-infrared spectroscopy. Oxygenated hemoglobin concentration will be recorded during single-task walking and dual-task walking. The outcome will be the dual-task-related change in oxygenated hemoglobin concentration, calculated as the mean oxygenated hemoglobin concentration during dual-task walking minus the mean oxygenated hemoglobin concentration during single-task walking. Results will be reported in micromoles per liter (µmol/L). A reduction in excessive dual-task-related prefrontal oxygenation after the intervention will be interpreted as improved neural efficiency, provided that walking and cognitive-task performance are maintained or improved.
-
Change in Global Walk Quality Index
Time frame: Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.
Overall gait quality will be assessed using the Global Walk Quality Index obtained from the Gait & Balance App. The Global Walk Quality Index is a single unitless composite indicator integrating walking speed, step length, step time, gait symmetry, and gait variability. These gait parameters will be combined according to the predefined Global Walk Quality Index calculation method, and only the resulting composite score will be reported under this outcome measure. Change will be calculated from baseline to each post-baseline assessment.
-
Change in Overall Balance Stability Index
Time frame: Baseline, immediately after the 8-12-week intervention, and at the 3-6-month follow-up.
Overall postural stability will be assessed using the ProKin Balance Platform under the foam eyes-closed condition. The Overall Balance Stability Index, generated by the ProKin software, will be used as the primary balance outcome. This composite index integrates anteroposterior and mediolateral postural sway into a single measure of overall balance performance. Lower values indicate better postural stability.
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Timed Up and Go Test Completion Time
Time frame: Baseline, post-intervention, and 3-6-month follow-up.
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time required to stand from a standard chair, walk 3 meters, turn, return, and sit down will be recorded.
Unit Seconds
-
Berg Balance Scale Total Score
Time frame: Baseline, post-intervention, and 3-6-month follow-up.
Balance performance will be assessed using the Berg Balance Scale (BBS). The total score ranges from 0 to 56, with higher scores indicating better balance performance.
Unit Total score (0-56)
-
Functional Reach Test Distance
Time frame: Baseline, post-intervention, and 3-6-month follow-up.
Dynamic balance will be assessed using the Functional Reach Test (FRT). The maximum forward reach distance while maintaining a fixed base of support will be measured.
Unit Centimeters
Study contacts
Contact information is provided by the study sponsor or research team.
Aisha Salim Alsuwaidi, PhD
CONTACT
Ibrahim Mostafa Abuamr, Professor
CONTACT
Sponsors and collaborators
Lead sponsor
University of Sharjah
Other
Registry information
Official study title
Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults: A Two-Phase Multimodal Investigation With a Phenotype-Guided Rehabilitation Trial
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jul 31, 2026
- Registry last updated
- Jul 31, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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