University of Antwerp
Antwerp, 2160, Belgium
Location status: Recruiting
NCT Number: NCT06345625
The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing.
Interested in participating?
Request Info65 year–100 year
All sexes
Observational
Antwerp, 2160, Belgium
Location status: Recruiting
Older adults above 65 years old experience falls at a rate of 20-40% annually, with women being more affected than men. Unintentional falls are the second leading cause of accidental injury death and a major contributor to disability levels worldwide. Falls pose an even bigger burden on society in the future due to the increasing number of older adults and the higher prevalence of falls as people age. Gait and balance instability are major risk and causative factors for falls in older adults. As people age, their stability decreases. This is evident in the careful way that older adults walk. To prevent and predict falls, it is essential to understand how humans maintain their stability during locomotor activities.
Balance disruptions are typically not caused by walking itself, but rather by internal or external disturbances or the performance of multiple tasks simultaneously. In daily life, people often face complex situations that require high levels of sensory input and cognitive processing. This can be especially challenging when also trying to maintain a safe walking pattern, such as when checking the environment before crossing the street. This task requires coordinated movement of both the head and eyes to track moving objects. Gaze control requires accurate cognitive processing, including multisensory integration, attention, executive functioning, and motor responses to coordinate eye and head movements.
Older adults use different strategies than younger adults to control head movement for stabilizing their head during walking. Therefore, changes in head position may affect gait stability differently in older adults. Ageing can cause frailty, decline in sensorimotor and cognitive abilities, and a reduced capacity to adjust gait to changing environments. These changes may increase the risk of falls in older adults. However, research on these issues is currently insufficient.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Frailty will be assessed using the Fried criteria, comprising 5 categories (each accounting for 1 point if scored positive): Unintentional weight loss (interview), weakness (grip strength with hand-held dynamometer), poor endurance and energy (two statements of the CES-D Depression Scale), slowness (walking speed over 15ft through gait analysis) and low physical activity level (Minnesota Leisure Time Activity questionnaire)(Fried et al., 2001).
Markers will be placed on the predefined anatomical locations and surface electrodes for electromyography will be applied at the predefined muscle locations following the SENIAM-guidelines. The Microsoft HoloLens 2 is fixated on the participant's head which will, on one hand, provide the cue to the participant for the head movement and on the other hand track eye and head movements. A safety harness is attached to the body and the ceiling of the lab. At the start of the trial, the subject will see a projection by the HoloLens 2 on the real environment moving to the left; right; upward; downward (cue in randomized order) which the participant is ought to follow with eyes and head. First while standing still and second while walking the 10-meter overground walkway at a self-preferred walking speed.
The researcher will visit the possible participants (at their home, community centre, etc.) and after written consent on screening procedure is provided, the tests for eligibility will be performed.
Participants are followed up for 12 months. They fill in a fall diary and telephone reminders will be performed monthly to encourage participants to complete and return their diaries.
Time frame: baseline
step length and width (cm)
Time frame: baseline
measure which estimates where the foot should be placed for stable gait
Time frame: baseline
latency in msec between onset of movements and activation recorded by surface EMG of bilateral m. Erector Spinae (trunk stabilization), m. Gluteus medius (hip strategy), m. Tibialis anterior and m. Soleus (ankle strategy)
Time frame: baseline
peak amplitude in microvolts of the surface EMG of bilateral m. Erector Spinae (trunk stabilization), m. Gluteus medius (hip strategy), m. Tibialis anterior and m. Soleus (ankle strategy)
Time frame: baseline
Duration of fixation of the eyes on target, measured by the Hololens 2
Time frame: baseline
Accuracy of the fixation of the eyes on target as measured by the Hololens 2
Time frame: baseline
Latency in msec between the movement of the target and the movement of the eyes and the head when following the target as measured by the Hololens 2.
Time frame: monthly during 12 months of follow-up
Fall diaries provide information on occurrence and number of falls, activity preceding a fall, cause of fall, obtained injuries and potential care that was received.
Time frame: baseline
reaction times in visual/sensory vs. visuo-sensory conditions (ratio, in %) measured with CatchU app
Time frame: baseline
number of correct symbol-digit pairs completed
Time frame: baseline
Time to complete part A vs. B (ratio in seconds)
Time frame: baseline
Accuracy (number of correct responses)
Time frame: baseline
joint position error in degrees
Time frame: baseline
directional accuracy (in %) of movement
Time frame: baseline
Amplitude (in mm) of movement
Time frame: baseline
VOR-gain and VOR-gain asymmetry in %
Time frame: baseline
statfHIT (Static visual acuity): logMAR-score and dynfHIT (Dynamic visual acuity): % correct responses
Time frame: baseline
Fried criteria: Frailty level (categorical): non-frail (0/5), pre-frail( 1-2/5) or frail (≥3/5)
Time frame: Screening before inclusion
age in years
Time frame: Screening before inclusion
male, female or other
Time frame: Screening before inclusion
presence or absence of diagnosed vestibulopathy, orthostatic hypotension, peripheral neuropathy, limb amputation, neurological/ or neuromuscular disorders affecting balance, neck disorders affecting sensorimotor control, blindness, deafness and if a full-time walking aid is indispensable
Time frame: Screening before inclusion
number of falls in last 12 months
Contact information is provided by the study sponsor or research team.
Ann Hallemans, PhD
CONTACT
Eugénie Lambrecht, MSc, PT
CONTACT
Universiteit Antwerpen
Other
Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults - a Multisensory Approach by Use of Mixed-reality
Acronym: BALANCAR
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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