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Recruiting NCT06573658

Neurophysiological Changes After Perturbation-based Training in Older Adults

No phase Interventional Falling Community Dwelling Older Adults Postural Stability Brain Connectivity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perturbation-based balance training (PBT), Walking exercise (control).
Who it may be relevant to
Registry conditions: Falling, Community Dwelling Older Adults, Postural Stability, Brain Connectivity. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Gray matter density in arbitrary units by structural Magnetic Resonance Imaging [Time frame: 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 [Time frame: pre-intervention, and within 1-week after the intervention]
Secondary outcome measures (12)
  • Postural stability [Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Number of laboratory-falls [Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • 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.]
  • Step time of the recovery steps in milliseconds (ms) [Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Step length of the recovery steps in millimeters (mm) [Time frame: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Trunk angle [Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Hip height in millimeters (mm) [Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • 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 tilting [Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Muscle activation onset latency in milliseconds [Time frame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • 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]
  • Cognitive flexibility and executive function [Time frame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT06573658 · HSEARS20230928002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗