Neurophysiological Changes After Perturbation-based Training in Older Adults

NCT06573658 | Recruiting DMC

• 1 other identifier: HSEARS20230928002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Falling; Community Dwelling Older Adults; Postural Stability; Brain Connectivity; Brain Structure

Keywords

Perturbation; Magnetic Resonance Image; MRI; step training; responsive postural control; balance; external disturbance; fall

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• Postural stability

  pre-intervention, within 1 week after intervention and 4 months after intervention

• Number of laboratory-falls

  pre-intervention, within 1 week after intervention and 4 months after intervention

• Number of real-life-falls

  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.

• Step time of the recovery steps in milliseconds (ms)

  pre-intervention, within 1 week after intervention and 4 months after intervention

• Step length of the recovery steps in millimeters (mm)

  pre-intervention, within 1 week after intervention and 4 months after intervention

Study Arms (2)

Perturbation-based balance training group

EXPERIMENTAL

This group will receive two sessions of treadmill walking at their comfortable speed involving perturbations

Behavioral: Perturbation-based balance training (PBT)

Control

PLACEBO COMPARATOR

This group will receive two sessions of treadmill walking at their comfortable speed involving no perturbations

Behavioral: Walking exercise (control)

Interventions

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.

Perturbation-based balance training group

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.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Sau Lan Tsang, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sau Lan Tsang, PhD

CONTACT

852 3400 8965; charlotte-sl.tsang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to PBT or active control group.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 27, 2024
• Study Start: April 18, 2024
• Primary Completion: October 14, 2025
• Study Completion (Estimated): October 14, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)