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NCT Number: NCT06774833

Self-initiated Perturbation-based Training in Older Adults

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Location status: Recruiting

Location contact

Sau Lan Tsang, PhD

CONTACT

852 3400 8965

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Self-initiated perturbation-based balance training

Behavioral

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 training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Generic balance ability

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  2. Mobility

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention

    Mobility will be assessed by Timed Up and Go test (in the unit of seconds).

  3. 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.

    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).

  4. Responsive postural adjustment upon translation

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  5. Responsive postural adjustment upon tilting

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  6. Dynamic balance

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds).

  7. Balance confidence

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  8. Functional lower body strength

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds).

  9. Cognitive flexibility and executive function

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds).

  10. Number of laboratory falls

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  11. Cognitive impairment

    Time frame: Pre-intervention.

    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.

  12. Depressive symptoms

    Time frame: Pre-intervention.

    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.

  13. Personality traits

    Time frame: Pre-intervention.

    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.

  14. Generic preference-based quality-of-life

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  15. Muscle activations

    Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.

    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.

  16. Physical activity

    Time frame: Pre-intervention, and 4 months after intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sau Lan Tsang, PhD

CONTACT

[email protected]

852 3400 8965

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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