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NCT Number: NCT06573658

Neurophysiological Changes After Perturbation-based Training in Older Adults

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.

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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

Georg Kranz, PhD

SUB_INVESTIGATOR

Roy Cheung, PhD

SUB_INVESTIGATOR

Sau Lan Tsang, PhD

CONTACT

[email protected]

852 3400 8965

Sau Lan Tsang, PhD

PRINCIPAL_INVESTIGATOR

Shamay Ng, PhD

SUB_INVESTIGATOR

Thomson Wong, PhD

SUB_INVESTIGATOR

Timothy Kwok, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Perturbation-based balance training (PBT)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Postural stability

    Time frame: pre-intervention, within 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 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.

  2. Number of laboratory-falls

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

    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.

  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 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.

  4. Step time of the recovery steps in milliseconds (ms)

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

    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.

  5. Step length of the recovery steps in millimeters (mm)

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

    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.

  6. Trunk angle

    Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention

    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.

  7. Hip height in millimeters (mm)

    Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention

    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.

  8. 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 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.

  9. Responsive postural adjustment upon tilting

    Time frame: pre-intervention, immediately after the 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.

  10. Muscle activation onset latency in milliseconds

    Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention

    Muscle latency will be collected from trunk and leg muscles using electromyography.

  11. 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

    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.

  12. Cognitive flexibility and executive function

    Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention

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

  13. Functional lower body strength

    Time frame: pre-intervention, immediately after the 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)

  14. Dynamic balance

    Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention

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

  15. Mobility

    Time frame: pre-intervention, immediately after the 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).

  16. White matter density in arbitrary units by structural Magnetic Resonance Imaging

    Time frame: pre-intervention, and immediately after the intervention

    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.

  17. Gray matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)

    Time frame: pre-intervention, and immediately after the intervention

    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.

  18. White matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)

    Time frame: pre-intervention, and immediately after the intervention

    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.

  19. Cortical thickness in mm measured by structural Magnetic Resonance Imaging

    Time frame: pre-intervention, and immediately after the intervention

    Cortical thickness in mm measured by structural MRI. The regions of interest include the cerebellar, inferior parietal, occipital, and frontal cortices.

  20. Fractional anisotropy ranges from 0-1 derived from Diffusion Tensor Imaging

    Time frame: pre-intervention, and immediately after the intervention

    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.

  21. Mean diffusivity measures in mm²/s by Diffusion Tensor Imaging

    Time frame: pre-intervention, and immediately after the intervention

    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.

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

Short-term Neurophysiological Changes After a Perturbation-based Training in Community-dwelling Older Adults: A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Sep 24, 2025

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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