Healthy Subjects (HS)NCT06774833
Self-initiated Perturbation-based Training in Older Adults
A study testing Self-initiated perturbation-based balance training and Conventional balance training in people with Healthy Subjects (HS), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is a single-blinded study. Participants will be randomly assigned to self-initiated perturbation-based balance training (SePBT) group or control (conventional balance training) group. Kinematic and Kinetic changes following SePBT group compared to control will be investigated. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- Self-initiated perturbation-based balance training and Conventional balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Nov 2024to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling adults aged 60 years old or older
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for at least 30 minutes
- Abbreviated Mental Test (Hong Kong version) scores≥6
- Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing.
Who cannot join
- Uncorrected vision or hearing impairment
- Osteoporosis
- Have a historyof hip or knee replacement
- Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety
- Participating or planning to participate in another fall prevention program.
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
About this study
Official title: Effect of Self-initiated Perturbation-based Balance Training on the Postural Stability of Community-dwelling Older Adults With An Increased Risk of Falling: A Randomized Controlled Trial
This is a single-blinded study. Participants will be randomly assigned to self-initiated perturbation-based balance training (SePBT) group or control (conventional balance training) group. Kinematic and Kinetic changes following SePBT group compared to control will be investigated.
Read the detailed description
Participants will be randomly assigned to two groups receiving SePBT or control group. All participants will give their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenient sampling in the local community. After baseline assessment, both groups will go through two 30-minute training session over two weeks. Between-group differences in behavior will be examined before and after training to identify training-induced changes in postural stability. 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
- Healthy Subjects (HS)
- Being tested
- Self-initiated perturbation-based balance training, Conventional balance training
- Keywords
- Perturbation, Step training, Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-initiated perturbation-based balance trainingBehavioural
This group will receive two 30-minute training sessions over two weeks, with one session per week. Participants will be required to recover their balance upon self-initiated perturbation.
Conventional balance trainingBehavioural
This group will receive two 30-minute training sessions over two weeks, with one session per week. Participants will be instructed to perform balance and strength training. The same training duration and format will be used as the Self-initiated perturbation-based balance training group.
| Study group | Role | What they receive |
|---|---|---|
| Self-initiated perturbation-based balance training group | Experimental | This group will receive two sessions of self-initiated perturbation-based balance training. Receives: Behavioral: Self-initiated perturbation-based balance training |
| Conventional balance training group | Active comparator | This group will receive two sessions of balance and strength training. Receives: Behavioral: Conventional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability
Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute center of mass (CoM) position in an anteroposterior direction relative to the closest edge of the Base of Support (BoS) 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, 1 week after intervention and 4 months after intervention.
Secondary outcomes (16)
Generic balance ability
Generic balance ability will be assessed by the Brief-BESTest. Brief-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for comprehensive examination of improvements that occur in reactive control. As a shortened version of the BESTest, the Brief-BESTest is an 8-item balance assessment containing 1 item for each of the 6 subsections of the BESTest.
Measured: Pre-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, 1 week after intervention and 4 months after intervention
Number of real-life falls
The number of real-life falls in months after randomization will be recorded. Fall circumstances and related injuries will be required 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, 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.
Responsive postural adjustment upon translation
Responsive postural adjustment upon translation will be assessed through Motor Control Test and Adaptation 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 12 translations of the standing platform in either forward or backward direction with medium and 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, 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, 1 week after intervention and 4 months after intervention.
Dynamic balance
Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds).
Measured: Pre-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, 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, 1 week after intervention and 4 months after intervention.
Cognitive flexibility and executive function
Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds).
Measured: Pre-intervention, 1 week after intervention and 4 months after intervention.
Number of laboratory falls
Participants will be exposed to one trip-like perturbation and slip-like perturbation on each foot at an unexpected time. The number of falls upon perturbations will be recorded.
Measured: Pre-intervention, 1 week after intervention and 4 months after intervention.
Cognitive impairment
Cognitive impairment will be assessed by Abbreviated Mental Test (AMT). AMT is a 10-item test, with a 10-point scale. A score less than 6 suggests a significant cognitive deficit.
Measured: Pre-intervention.
Depressive symptoms
Depressive symptoms will be assessed by Five-Item Geriatric Depression Scale. Participants will be asked to answer 5 questions as yes or no. The answer "no" for the first question and "yes" for the other four questions will be evaluated for depression.
Measured: Pre-intervention.
Personality traits
Personality traits assessed by Ten-Item Personality Inventory. It has 10 items, each item adopts a 5-level score of 1 (Disagree strongly) to 5 (Agree strongly), and a higher dimension score indicates a stronger individual's personality proneness.
Measured: Pre-intervention.
Generic preference-based quality-of-life
Generic preference-based quality-of-life will be assessed by five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
In the EQ-5D descriptive system, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each health state is identified by a five-digit code, with 11111 representing the best and 55555 the worst possible health state.
In the EQ CAS, the scale value is from 0 to 100, with higher values representing higher balance confidence.
Measured: Pre-intervention, 1 week after intervention and 4 months after intervention.
Muscle activations
Muscle activations will be assessed by surface electromyography using an electromyography system (Trigno IM, Delsys Inc., Natick, MA, USA). Fourteen electrodes are placed bilaterally over erector spinae, rectus abdominis, gastrocnemius medialis, biceps femoris, rectus femoris, tibialis anterior, and gluteus medius according to the SENIAM guidelines (www.seniam.org) by the physical therapist.
Measured: Pre-intervention, 1 week after intervention and 4 months after intervention.
Physical activity
Physical activity will be assessed by the Physical Activity Scale for the Elderly. This questionnaire will ask participants to recall their activity over the last 7-days. Activity types include sitting, walking, sport/recreation, exercise, occupational and household. A total score for physical activity can be calculated using these answers and the predetermined weights associated with each activity.
Measured: Pre-intervention, and 4 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start6 Nov 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to SePBT or conventional balance training group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774833
- Sponsor's protocol ID
- HSEARS20240505001
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2025
- Last updated
- 24 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-initiated Perturbation-based Balance Training on the Postural Stability of Community-dwelling Older Adults With An Increased Risk of Falling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06774833
- Acronym / sponsor ID
- HSEARS20240505001
- Conditions
- Healthy Subjects (HS)
- Keywords
- Perturbation, Step training, Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (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 a single-blinded study. Participants will be randomly assigned to self-initiated perturbation-based balance training (SePBT) group or control (conventional balance training) group. Kinematic and Kinetic changes following SePBT group compared to control will be investigated.
Detailed description
Participants will be randomly assigned to two groups receiving SePBT or control group. All participants will give their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenient sampling in the local community. After baseline assessment, both groups will go through two 30-minute training session over two weeks. Between-group differences in behavior will be examined before and after training to identify training-induced changes in postural stability. 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to SePBT or conventional balance training group.
| Arm | Type | Receives |
|---|---|---|
| Self-initiated perturbation-based balance training group | Experimental | Behavioral: Self-initiated perturbation-based balance trainingThis group will receive two sessions of self-initiated perturbation-based balance training. |
| Conventional balance training group | Active comparator | Behavioral: Conventional balance trainingThis group will receive two sessions of balance and strength training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling adults aged 60 years old or older
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for at least 30 minutes
- Abbreviated Mental Test (Hong Kong version) scores≥6
- Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing.
Key exclusion criteria (5 listed)
- Uncorrected vision or hearing impairment
- Osteoporosis
- Have a historyof hip or knee replacement
- Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety
- Participating or planning to participate in another fall prevention program.
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 |
|---|---|---|
| Self-initiated perturbation-based balance trainingThis group will receive two 30-minute training sessions over two weeks, with one session per week. Participants will be required to recover their balance upon self-initiated perturbation. | Behavioural | Self-initiated perturbation-based balance training group |
| Conventional balance trainingThis group will receive two 30-minute training sessions over two weeks, with one session per week. Participants will be instructed to perform balance and strength training. The same training duration and format will be used as the Self-initiated perturbation-based balance training group. | Behavioural | Conventional balance training group |
Primary outcome
Postural stability
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute center of mass (CoM) position in an anteroposterior direction relative to the closest edge of the Base of Support (BoS) 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.
16 secondary outcomes
Generic balance ability
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Mobility
Time frame: Pre-intervention, 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.
Responsive postural adjustment upon translation
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Responsive postural adjustment upon tilting
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Dynamic balance
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Balance confidence
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Functional lower body strength
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Cognitive flexibility and executive function
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Number of laboratory falls
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Cognitive impairment
Time frame: Pre-intervention.
Depressive symptoms
Time frame: Pre-intervention.
Personality traits
Time frame: Pre-intervention.
Generic preference-based quality-of-life
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Muscle activations
Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Physical activity
Time frame: Pre-intervention, and 4 months after 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 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-initiated perturbation-based balance training and Conventional balance training in people with Healthy Subjects (HS), 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 5 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 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 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. 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?
Postural stability (time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.). 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 Jul 2026.