Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults

Aged Clinical Trial

— BALANCAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345625
• Other study ID #: 6012
• Status: Recruiting
• Start date: May 7, 2024
• Est. completion date: January 2028

Study information

• Verified date: May 2024
• Source: Universiteit Antwerpen
• Contact: Ann Hallemans, PhD
• Phone: 032652912
• Email: ann.hallemans[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Accidental Fall
• Aged
• Gait
• Postural Balance

Intervention

Diagnostic Test:
• Cognition
The CatchU® app quantitatively and objectively measures the ability to integrate visual-somatosensory information using reaction time test data. Digit Symbol Substitution test assesses processing speed and attention by requiring individuals to match symbols with corresponding numbers within a specified time frame. 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). 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
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. 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. For the assessment of static and dynamic visual acuity, functional Head Impulse Testing (fHIT) will be used.
• Frailty
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).

Other:
• Biomechanical movement analysis
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.
• Screening
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. Interview: asking about age (years), gender (male/female), medical history and the number of falls in the last 12 months . 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
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.

Locations

Country	Name	City	State
Belgium	University of Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

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