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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.

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Official record

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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
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

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
  • The Hong Kong Polytechnic University

    Hong Kong

    Sau Lan Tsang, PhD, 852 3400 8965

    Recruiting

Other trials in Hong Kong

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.

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 groups in NCT06774833
Study groupRoleWhat they receive
Self-initiated perturbation-based balance training groupExperimentalThis group will receive two sessions of self-initiated perturbation-based balance training.
Receives: Behavioral: Self-initiated perturbation-based balance training
Conventional balance training groupActive comparatorThis 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.

  1. 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)
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  1. First posted14 Jan 2025
  2. Study start6 Nov 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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