Neurophysiological Changes After Perturbation-based Training in Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Connectivity; Falling; Postural Stability; Community Dwelling Older Adults; Brain Structure
• Intervention / Treatment: Behavioral: Perturbation-based balance training (PBT); Behavioral: Walking exercise (control)

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 Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sau Lan Tsang, PhD; Phone Number: 852 3400 8965; Email: charlotte-sl.tsang@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Sau Lan Tsang, PhD; Phone Number: 852 3400 8965; Email: charlotte-sl.tsang@polyu.edu.hk
    • Principal Investigator: Sau Lan Tsang, PhD
    • Sub-Investigator: Georg Kranz, PhD
    • Sub-Investigator: Thomson Wong, PhD
    • Sub-Investigator: Roy Cheung, PhD
    • Sub-Investigator: Timothy Kwok, MD
    • Sub-Investigator: Shamay Ng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perturbation-based balance training group; This group will receive two sessions of treadmill walking at their comfortable speed involving perturbations	Behavioral: 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.
Placebo Comparator: Control; This group will receive two sessions of treadmill walking at their comfortable speed involving no perturbations	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	pre-intervention, and within 1-week after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.	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.	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.	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.	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.	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)	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)	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)	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).	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.	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.	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.	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.	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.	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.	pre-intervention, and immediately after the intervention
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.	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.	pre-intervention, within 1 week after intervention and 4 months after 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.	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.	pre-intervention, within 1 week after intervention and 4 months after intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Sau Lan Tsang, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): October 14, 2025
• Study Completion (Estimated): October 14, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: MRI; balance; step training; fall; Perturbation; Magnetic Resonance Image; responsive postural control; external disturbance
• Other Study ID Numbers: HSEARS20230928002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No