Accidental Falls/Prevention & ControlNCT07739056
Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults
A study testing Personalized Neurophysiological Rehabilitation and Conventional Fall-Prevention Exercise Program in people with Accidental Falls/Prevention & Control, run by University of Sharjah at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls/Prevention & Control
- What is being tested?
- Personalized Neurophysiological Rehabilitation and Conventional Fall-Prevention Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 31 Dec 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site
University of Sharjah
Sharjah city
Ibrahim M Abuamr, professor, +97165055713, iabuamr@sharjah.ac.ae
Aisha S Alsuwaidi, PhD
About this study
Official title: Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults: A Two-Phase Multimodal Investigation With a Phenotype-Guided Rehabilitation 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:
Read more
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
Read the detailed description
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.
- Conditions
- Accidental Falls/Prevention & Control
- Being tested
- Personalized Neurophysiological Rehabilitation, Conventional Fall-Prevention Exercise Program
- Keywords
- Fall risk, Older adults, Balance, Neural control, Cognitive-motor integration, Phenotype-guided therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Neurophysiological RehabilitationOther
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.
Conventional Fall-Prevention Exercise ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Fall-Prevention Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (%)
Measured: 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 (%)
Measured: 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
Measured: 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 (%)
Measured: 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 (%)
Measured: 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
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
Measured: During the 3- to 6-month follow-up period after completion of the intervention.
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)
Measured: During the 3- to 6-month follow-up period after completion of the intervention.
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.
Measured: Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month
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.
Measured: 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
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.
Measured: Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.
Change in Global Walk Quality Index
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.
Measured: Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.
Change in Overall Balance Stability Index
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.
Measured: Baseline, immediately after the 8-12-week intervention, and at the 3-6-month follow-up.
Timed Up and Go Test Completion Time
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
Measured: Baseline, post-intervention, and 3-6-month follow-up.
Berg Balance Scale Total Score
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)
Measured: Baseline, post-intervention, and 3-6-month follow-up.
Functional Reach Test Distance
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
Measured: Baseline, post-intervention, and 3-6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Falls/Prevention & ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha Salim Alsuwaidi, University of Sharjah
- Investigators
- Ibrahim Moustafa Abuamer, professor, Study director, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739056
- Sponsor's protocol ID
- USharjah2026
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults: A Two-Phase Multimodal Investigation With a Phenotype-Guided Rehabilitation Trial
- ClinicalTrials.gov ID
- NCT07739056
- Acronym / sponsor ID
- USharjah2026
- Conditions
- Accidental Falls/Prevention & Control
- Keywords
- Fall risk, Older adults, Balance, Neural control, Cognitive-motor integration, Phenotype-guided therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 RehabilitationParticipants 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 ProgramParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following 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.
Key exclusion criteria (7 listed)
- Participants will be excluded if they have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Neurophysiological RehabilitationThe 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 | Phase 2: Randomized Controlled Trial (Intervention) / Personalized Neurophysiological Rehabilitation |
| Conventional Fall-Prevention Exercise ProgramThe 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 | Other | Phase 2: Randomized Controlled Trial (Intervention)/Conventional Fall-Prevention Exercise Program |
Primary outcome
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 (%)
10 secondary outcomes
Number of Falls per Participant
Time frame: During the 3- to 6-month follow-up period after completion of the intervention.
Time to First Fall
Time frame: During the 3- to 6-month follow-up period after completion of the intervention.
Neurophysiological Outcomes (Corticomuscular Coherence (CMC))
Time frame: Phase 1 at baseline, post phase 2 intervention 8-12 weeks, and follow up 3-6 month
Neurophysiological Outcomes (Intermuscular Coherence (IMC))
Time frame: 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
Time frame: Baseline, immediately after completion of the 8-12-week intervention, and at the 3-6-month follow-up.
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.
Change in Overall Balance Stability Index
Time frame: Baseline, immediately after the 8-12-week intervention, and at the 3-6-month follow-up.
Timed Up and Go Test Completion Time
Time frame: Baseline, post-intervention, and 3-6-month follow-up.
Berg Balance Scale Total Score
Time frame: Baseline, post-intervention, and 3-6-month follow-up.
Functional Reach Test Distance
Time frame: Baseline, post-intervention, and 3-6-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. No plan to make IPD available to other researchers.
Related trials for Accidental Falls/Prevention & Control
Enrolling by invitation
Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology
Fall Risk, Fall Risk, Fall Prevention
Enrolling by invitation
Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications
Accidental Falls/Prevention and Control, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ibrahim Moustafa Abuamer, professor study director
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Neurophysiological Rehabilitation and Conventional Fall-Prevention Exercise Program in people with Accidental Falls/Prevention & Control, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aisha Salim Alsuwaidi, PhD (+971507373053, U25100059@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From initiation of recruitment until enrollment of the final participant, anticipated period of (12 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.