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Clinical Trials/NCT06345625
NCT06345625
Recruiting
N/A

Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults - a Multisensory Approach by Use of Mixed-reality

Universiteit Antwerpen1 site in 1 country100 target enrollmentMay 7, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aged
Sponsor
Universiteit Antwerpen
Enrollment
100
Locations
1
Primary Endpoint
Foot placement estimator
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2024
End Date
January 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Hallemans

Associate Professor

Universiteit Antwerpen

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.

Outcomes

Primary Outcomes

Foot placement estimator

Time Frame: baseline

measure which estimates where the foot should be placed for stable gait

Latency

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.

Fall characteristics

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.

Spatio-temporal parameters of gait

Time Frame: baseline

step length and width (cm)

Fixation duration

Time Frame: baseline

Duration of fixation of the eyes on target, measured by the Hololens 2

Peak amplitude

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)

Onset latency

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)

Gain

Time Frame: baseline

Accuracy of the fixation of the eyes on target as measured by the Hololens 2

Secondary Outcomes

  • Digit symbol substitution test(baseline)
  • fHIT(baseline)
  • Trail making test(baseline)
  • vHIT(baseline)
  • Go/No Go test(baseline)
  • Fly test(baseline)
  • Multisensory integration(baseline)
  • Head Repositioning Accuracy(baseline)
  • Frailty(baseline)

Study Sites (1)

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