FallingNCT06573658
Neurophysiological Changes After Perturbation-based Training in Older Adults
A study testing Perturbation-based balance training (PBT) in people with Falling and Community Dwelling Older Adults, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to a perturbation-based training (PBT) or a walking (control) group. Changes in postural stability and neurophysiology in the brain following PBT compared to walking exercise without perturbation will be investigated. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falling, Community Dwelling Older Adults, Postural Stability
- What is being tested?
- Perturbation-based balance training (PBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Apr 2024to 14 Oct 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 60 years old
- Community-dwelling
- Right-handed
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for ≥ 30 minutes
- Abbreviated Mental Test (Hong Kong version) score ≥ 6
Who cannot join
- Metal implants (e.g. pacemaker, artificial cochlea)
- Uncorrected vision or hearing impairment
- Osteoporosis
- Hip or knee replacement within the last year
- Musculoskeletal, cardiovascular, mental, or neurological disorders (such as Parkinson's disease) which can affect MRI examination, balance control, or exercise participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Sau Lan Tsang, PhD, 852 3400 8965, charlotte-sl.tsang@polyu.edu.hk
Sau Lan Tsang, PhD
About this study
Official title: Short-term Neurophysiological Changes After a Perturbation-based Training in Community-dwelling Older Adults: A Pilot Study
This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to a perturbation-based training (PBT) or a walking (control) group. Changes in postural stability and neurophysiology in the brain following PBT compared to walking exercise without perturbation will be investigated.
Read the detailed description
A total of 88 participants will be randomly assigned to two groups receiving perturbation-based training (PBT) or walking exercise without perturbation (control). Written informed consent will be obtained from participants prior to the baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. Both groups will receive two sessions of treadmill walking at their comfortable speed. Perturbations will be induced during treadmill walking only for the PBT group. As informed from previous literature, two sessions of PBT could have improved postural stability for up to 1.5 years. Between-group differences in behavioural and MRI findings will be examined before and after training to identify training-induced changes in postural stability, brain structures, and functional connectivities. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.
- Conditions
- Falling, Community Dwelling Older Adults, Postural Stability, Brain Connectivity, Brain Structure
- Being tested
- Perturbation-based balance training (PBT), Walking exercise (control)
- Keywords
- Perturbation, Magnetic Resonance Image, MRI, step training, responsive postural control, balance, external disturbance, fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation-based balance training (PBT)Behavioural
It will be a two-session training with each session lasting for approximately an hour. Perturbations will be induced during treadmill walking. Participants will be instructed to recover their balance and continue walking after the perturbations.
Walking exercise (control)Behavioural
It will be a two-session training with each session lasting for approximately an hour. The same training duration and format will be used as the PBT group, except that no perturbations will be induced during the treadmill walking.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation-based balance training group | Experimental | This group will receive two sessions of treadmill walking at their comfortable speed involving perturbations Receives: Behavioral: Perturbation-based balance training (PBT) |
| Control | Placebo comparator | This group will receive two sessions of treadmill walking at their comfortable speed involving no perturbations Receives: Behavioral: Walking exercise (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gray matter density in arbitrary units by structural Magnetic Resonance Imaging
Gray matter density at cortical and subcortical regions will be taken by structural MRI. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and within 1-week after the intervention
Brain connectivity derived from the correlation between the Blood-oxygen-level-dependent (BOLD) signals from different brain regions in arbitrary units obtained during functional MRI
BOLD signal reflecting the brain connectivity during rest will be taken through resting-state functional MRI, during which subjects are instructed to relax with eyes open, to let their mind wander, and not think of anything specific. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and within 1-week after the intervention
Secondary outcomes (21)
Postural stability
Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute CoM position in an anteroposterior direction relative to the closest edge of Base of Support (BoS) and normalized by foot length.
The absolute CoM position and BoS position will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.
Measured: pre-intervention, within 1 week after intervention and 4 months after intervention
Number of laboratory-falls
The number of laboratory-falls following perturbation during assessment sessions will be recorded. A fall will be defined if there is a body-weight support of 30% or more from the full-body safety harness.
Measured: pre-intervention, within 1 week after intervention and 4 months after intervention
Number of real-life-falls
The number of real-life falls in 12 months after randomization will be recorded. Fall circumstances and related injuries will be enquired via phone contact. A fall is defined as an event resulting in a person unintentionally coming to rest on the ground or other lower level, not as the result of a major intrinsic event e.g., syncope, stroke, seizure, or overwhelming hazard such as an earthquake.
Measured: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
Step time of the recovery steps in milliseconds (ms)
Step time of the recovery steps after the perturbation will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.
Measured: pre-intervention, within 1 week after intervention and 4 months after intervention
Step length of the recovery steps in millimeters (mm)
Step length of the recovery steps after the perturbation will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.
Measured: pre-intervention, within 1 week after intervention and 4 months after intervention
Trunk angle
The trunk angle at the recovery steps after the perturbation will be calculated as the angle between the trunk segment with the vertical line. The position of the trunk will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.
Measured: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Hip height in millimeters (mm)
Hip height at the recovery steps after the perturbation will be calculated as the vertical distance from the ground to the midpoint of bilateral hips and normalized by the subjects' height. The positions of bilateral hips will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.
Measured: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Responsive postural adjustment upon translation
Responsive postural adjustment upon translation will be assessed through Motor Control Test on a computerized dynamic posturography (Bertec® Balance Advantage® Dynamic System, Bertec® Corporation, Columbus, USA). During the Motor Control Test, participants will be requested to maintain their standing balance in response to 18 translations of the standing platform in either forward or backward direction with small, medium or large amplitudes. Weight symmetry, latency of reaction, and amplitude of sway will be recorded. Full-body safety harness will be worn throughout the tests to protect the participants from any potential loss of balance.
Measured: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Responsive postural adjustment upon tilting
Responsive postural adjustment upon tilting will be assessed through Adaptation Test on a computerized dynamic posturography (Bertec® Balance Advantage® Dynamic System, Bertec® Corporation, Columbus, USA). During the Adaptation Test, the force platform will either tilt up or down for a total of 10 repetitions. Sway energy will be recorded. Full-body safety harness will be worn throughout the tests to protect the participants from any potential loss of balance.
Measured: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Muscle activation onset latency in milliseconds
Muscle latency will be collected from trunk and leg muscles using electromyography.
Measured: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Balance confidence
Balance confidence will be measured with the Chinese version of the shortened version of Activities-Specific Balance Confidence Scale (ABC-6). The scale value is from 0 to 100, with higher values representing higher balance confidence.
Measured: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention, and at the last prospective fall follow-up
Cognitive flexibility and executive function
Cognitive flexibility and executive function assessed by Trial Making Tests A and B (in the unit of seconds)
Measured: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
Functional lower body strength
Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds)
Measured: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
Dynamic balance
Dynamic balance will be assessed by Alternate Step Test (in the unit of seconds)
Measured: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
Mobility
Mobility will be assessed by Timed Up and Go test (in the unit of seconds).
Measured: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
White matter density in arbitrary units by structural Magnetic Resonance Imaging
White matter density at cortical and subcortical regions will be taken by structural MRI. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and immediately after the intervention
Gray matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)
Gray matter volume at cortical and subcortical regions will be measured by Structural MRI. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and immediately after the intervention
White matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)
White matter volume at cortical and subcortical regions will be measured by Structural MRI. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and immediately after the intervention
Cortical thickness in mm measured by structural Magnetic Resonance Imaging
Cortical thickness in mm measured by structural MRI. The regions of interest include the cerebellar, inferior parietal, occipital, and frontal cortices.
Measured: pre-intervention, and immediately after the intervention
Fractional anisotropy ranges from 0-1 derived from Diffusion Tensor Imaging
The degree of anisotropy of water diffusion in white matter tracts will be derived from the diffusion tensor. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and immediately after the intervention
Mean diffusivity measures in mm²/s by Diffusion Tensor Imaging
Mean diffusivity will be derived from the diffusion tensor. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Measured: pre-intervention, and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start18 Apr 2024
- Primary completion14 Oct 2025 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to PBT or active control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sau Lan Tsang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573658
- Sponsor's protocol ID
- HSEARS20230928002
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Neurophysiological Changes After a Perturbation-based Training in Community-dwelling Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT06573658
- Acronym / sponsor ID
- HSEARS20230928002
- Conditions
- Falling, Community Dwelling Older Adults, Postural Stability, Brain Connectivity, Brain Structure
- Keywords
- Perturbation, Magnetic Resonance Image, MRI, step training, responsive postural control, balance, external disturbance, fall
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 14 Oct 2025 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 27 Aug 2024 (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.
This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to a perturbation-based training (PBT) or a walking (control) group. Changes in postural stability and neurophysiology in the brain following PBT compared to walking exercise without perturbation will be investigated.
Detailed description
A total of 88 participants will be randomly assigned to two groups receiving perturbation-based training (PBT) or walking exercise without perturbation (control). Written informed consent will be obtained from participants prior to the baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. Both groups will receive two sessions of treadmill walking at their comfortable speed. Perturbations will be induced during treadmill walking only for the PBT group. As informed from previous literature, two sessions of PBT could have improved postural stability for up to 1.5 years. Between-group differences in behavioural and MRI findings will be examined before and after training to identify training-induced changes in postural stability, brain structures, and functional connectivities. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to PBT or active control group.
| Arm | Type | Receives |
|---|---|---|
| Perturbation-based balance training group | Experimental | Behavioral: Perturbation-based balance training (PBT)This group will receive two sessions of treadmill walking at their comfortable speed involving perturbations |
| Control | Placebo comparator | Behavioral: Walking exercise (control)This group will receive two sessions of treadmill walking at their comfortable speed involving no perturbations |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 60 years old
- Community-dwelling
- Right-handed
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for ≥ 30 minutes
Key exclusion criteria (5 listed)
- Metal implants (e.g. pacemaker, artificial cochlea)
- Uncorrected vision or hearing impairment
- Osteoporosis
- Hip or knee replacement within the last year
- Musculoskeletal, cardiovascular, mental, or neurological disorders (such as Parkinson's disease) which can affect MRI examination, balance control, or exercise participation.
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 |
|---|---|---|
| Perturbation-based balance training (PBT)It will be a two-session training with each session lasting for approximately an hour. Perturbations will be induced during treadmill walking. Participants will be instructed to recover their balance and continue walking after the perturbations. | Behavioural | Perturbation-based balance training group |
| Walking exercise (control)It will be a two-session training with each session lasting for approximately an hour. The same training duration and format will be used as the PBT group, except that no perturbations will be induced during the treadmill walking. | Behavioural | Control |
Primary outcome
Gray matter density in arbitrary units by structural Magnetic Resonance Imaging
Time frame: pre-intervention, and within 1-week after the intervention
Gray matter density at cortical and subcortical regions will be taken by structural MRI. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Brain connectivity derived from the correlation between the Blood-oxygen-level-dependent (BOLD) signals from different brain regions in arbitrary units obtained during functional MRI
Time frame: pre-intervention, and within 1-week after the intervention
BOLD signal reflecting the brain connectivity during rest will be taken through resting-state functional MRI, during which subjects are instructed to relax with eyes open, to let their mind wander, and not think of anything specific. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
21 secondary outcomes
Postural stability
Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention
Number of laboratory-falls
Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention
Number of real-life-falls
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
Step time of the recovery steps in milliseconds (ms)
Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention
Step length of the recovery steps in millimeters (mm)
Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention
Trunk angle
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Hip height in millimeters (mm)
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Responsive postural adjustment upon translation
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Responsive postural adjustment upon tilting
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Muscle activation onset latency in milliseconds
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
Balance confidence
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention, and at the last prospective fall follow-up
Cognitive flexibility and executive function
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
Functional lower body strength
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
Dynamic balance
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
Mobility
Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
White matter density in arbitrary units by structural Magnetic Resonance Imaging
Time frame: pre-intervention, and immediately after the intervention
Gray matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)
Time frame: pre-intervention, and immediately after the intervention
White matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)
Time frame: pre-intervention, and immediately after the intervention
Cortical thickness in mm measured by structural Magnetic Resonance Imaging
Time frame: pre-intervention, and immediately after the intervention
Fractional anisotropy ranges from 0-1 derived from Diffusion Tensor Imaging
Time frame: pre-intervention, and immediately after the intervention
Mean diffusivity measures in mm²/s by Diffusion Tensor Imaging
Time frame: pre-intervention, and immediately after the intervention
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 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Sau Lan Tsang, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perturbation-based balance training (PBT) in people with Falling and Community Dwelling Older Adults, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 Sau Lan Tsang, PhD (852 3400 8965, charlotte-sl.tsang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gray matter density in arbitrary units by structural Magnetic Resonance Imaging (time frame: pre-intervention, and within 1-week after the intervention). The study lists 2 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 24 Sep 2025.