Aged Clinical Trial
— BALANCAROfficial title:
Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults - a Multisensory Approach by Use of Mixed-reality
NCT number | NCT06345625 |
Other study ID # | 6012 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 7, 2024 |
Est. completion date | January 2028 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2028 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University of Antwerp | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | age in years | Screening before inclusion | |
Other | Gender | male, female or other | Screening before inclusion | |
Other | Medical history | 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 | Screening before inclusion | |
Other | Fall history | number of falls in last 12 months | Screening before inclusion | |
Primary | Spatio-temporal parameters of gait | step length and width (cm) | baseline | |
Primary | Foot placement estimator | measure which estimates where the foot should be placed for stable gait | baseline | |
Primary | Onset latency | 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) | baseline | |
Primary | Peak amplitude | 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) | baseline | |
Primary | Fixation duration | Duration of fixation of the eyes on target, measured by the Hololens 2 | baseline | |
Primary | Gain | Accuracy of the fixation of the eyes on target as measured by the Hololens 2 | baseline | |
Primary | Latency | 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. | baseline | |
Primary | Fall characteristics | 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. | monthly during 12 months of follow-up | |
Secondary | Multisensory integration | reaction times in visual/sensory vs. visuo-sensory conditions (ratio, in %) measured with CatchU app | baseline | |
Secondary | Digit symbol substitution test | number of correct symbol-digit pairs completed | baseline | |
Secondary | Trail making test | Time to complete part A vs. B (ratio in seconds) | baseline | |
Secondary | Go/No Go test | Accuracy (number of correct responses) | baseline | |
Secondary | Head Repositioning Accuracy | joint position error in degrees | baseline | |
Secondary | Fly test | directional accuracy (in %) of movement | baseline | |
Secondary | Fly test | Amplitude (in mm) of movement | baseline | |
Secondary | vHIT | VOR-gain and VOR-gain asymmetry in % | baseline | |
Secondary | fHIT | statfHIT (Static visual acuity): logMAR-score and dynfHIT (Dynamic visual acuity): % correct responses | baseline | |
Secondary | Frailty | Fried criteria: Frailty level (categorical): non-frail (0/5), pre-frail( 1-2/5) or frail (=3/5) | baseline |
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