About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Community dwelling
an age of 65 years or above
Disqualifiers
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.
Trial population
Community dwelling older adults with an age of 65 years or above
Trial design
Case-control
Prospective
Treatments tested in this trial
Cognition
Diagnostic test1. The CatchU® app quantitatively and objectively measures the ability to integrate visual-somatosensory information using reaction time test data. 2. Digit Symbol Substitution test assesses processing speed and attention by requiring individuals to match symbols with corresponding numbers within a specified time frame. 3. Trail Making Test part 1 and 2: assesses cognitive flexibility, visual attention, and task-switching by having individuals connect numbered circles in sequence (part 1) and then alternate between numbers and letters (Part 2). 4. Go/No Go test measures an individual's ability to inhibit a prepotent response (No-Go) and execute a response when required (Go). This test provides insights into executive functioning, particularly inhibitory control.
Sensory function
Diagnostic test1. Cervical Sensorimotor control will be measured through a wireless wearable sensor 3D-cervical trainer by Sensamove on the placed on the head of the participant. The 3DCT registers cervical position sense by the Head Repositioning Accuracy test where the subject must relocate the head to the previously memorized (neutral) head position with the eyes closed and the joint position error degrees are registered. Cervical movement sense is examined using 'The Fly'-test where the subject ought to follow a movement pattern displayed on the screen in front of them. The movement of the neck-head unit is there upon tracked by the 3DCT and projected on the screen. 2. Vestibular function will be assessed through 3D-video Head Impulse Testing (vHIT), examining the state of the three semicircular canals by delivering the vestibulo-ocular reflex (vor) gain and vor gain asymmetry. 3. For the assessment of static and dynamic visual acuity, functional Head Impulse Testing (fHIT) will be used.
Frailty
Diagnostic testFrailty 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).
Biomechanical movement analysis
Other interventionMarkers 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.
Screening
Other interventionThe 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. 1. Interview: asking about age (years), gender (male/female), medical history and the number of falls in the last 12 months . 2. Timed Up-and-Go (TUG) to check walking ability. TUG is a sensitive and specific measure for identifying risk for falls (Shumway-Cook et al., 2000).
Follow up
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Spatio-temporal parameters of gait
step length and width (cm)
Foot placement estimator
measure which estimates where the foot should be placed for stable gait
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)
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)
Secondary outcomes
Multisensory integration
reaction times in visual/sensory vs. visuo-sensory conditions (ratio, in %) measured with CatchU app
Digit symbol substitution test
number of correct symbol-digit pairs completed
Trail making test
Time to complete part A vs. B (ratio in seconds)
Go/No Go test
Accuracy (number of correct responses)
Other outcomes
Age
age in years
Gender
male, female or 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
Fall history
number of falls in last 12 months
Sponsors and contacts
Click on the lead sponsor to view all of their trials.