Clinical trial NCT06345625: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults
Official title: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults - a Multisensory Approach by Use of Mixed-reality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aged
Accidental Fall
Postural Balance
Gait
Keywords: older adults
Sensorimotor integration
visual tracking while walking
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling older adults with an age of 65 years or above

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Community dwelling
* an age of 65 years or above

Exclusion Criteria:

* age \< 65 years
* medical history encompassing diagnosed vestibulopathy, orthostatic hypotension, peripheral neuropathy, limb amputation, neurological or neuromuscular disorders affecting balance, diagnosed neck disorders affecting sensorimotor control, blindness, deafness
* a full-time walking aid is indispensable.

Primary outcomes:
measure: Spatio-temporal parameters of gait
timeFrame: baseline
measure: Foot placement estimator
timeFrame: baseline
measure: Onset latency
timeFrame: baseline
measure: Peak amplitude
timeFrame: baseline
measure: Fixation duration
timeFrame: baseline
measure: Gain
timeFrame: baseline
measure: Latency
timeFrame: baseline
measure: Fall characteristics
timeFrame: monthly during 12 months of follow-up
Secondary outcomes:
measure: Multisensory integration
timeFrame: baseline
measure: Digit symbol substitution test
timeFrame: baseline
measure: Trail making test
timeFrame: baseline
measure: Go/No Go test
timeFrame: baseline
measure: Head Repositioning Accuracy
timeFrame: baseline
measure: Fly test
timeFrame: baseline
measure: Fly test
timeFrame: baseline
measure: vHIT
timeFrame: baseline
measure: fHIT
timeFrame: baseline
measure: Frailty
timeFrame: baseline
Other outcomes:
measure: Age
timeFrame: Screening before inclusion
measure: Gender
timeFrame: Screening before inclusion
measure: Medical history
timeFrame: Screening before inclusion
measure: Fall history
timeFrame: Screening before inclusion
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Ann Hallemans
role: PRINCIPAL_INVESTIGATOR
References: