Neurophysiological Changes After Perturbation-based Training in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥ 60 years old
Community-dwelling
Right-handed
Able to communicate effectively in Cantonese or Mandarin
Disqualifiers
Metal implants (e.g. pacemaker, artificial cochlea)
Uncorrected vision or hearing impairment
Osteoporosis
Hip or knee replacement within the last year
Trial design
Design model
Parallel
Treatments tested in this trial
Perturbation-based balance training (PBT)
BehavioralIt 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)
BehavioralIt 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Perturbation-based balance training groupExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
pre-intervention, and within 1-week after the intervention2
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.
Time frame
pre-intervention, and within 1-week after the interventionSecondary outcomes
1
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.
Time frame
pre-intervention, within 1 week after intervention and 4 months after intervention2
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.
Time frame
pre-intervention, within 1 week after intervention and 4 months after intervention3
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.
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.4
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.
Time frame
pre-intervention, within 1 week after intervention and 4 months after interventionSponsors and contacts
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Source ClinicalTrials.gov