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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gait; Aged; Accidental Fall; Postural Balance
• Intervention / Treatment: Diagnostic test: Cognition; Diagnostic test: Sensory function; Diagnostic test: Frailty; Other: Biomechanical movement analysis; Other: Screening; Other: Follow up

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ann Hallemans, PhD; Phone Number: 032652912; Email: ann.hallemans@uantwerpen.be
• Study Contact Backup: Name: Eugénie Lambrecht, MSc, PT; Email: eugenie.lambrecht@uantwerpen.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2160
    • Recruiting
    • University of Antwerp
    • Contact: Ann Hallemans, PhD; Phone Number: +32 3 265 29 12; Email: ann.hallemans@uantwerpen.be
    • Contact: PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Community dwelling older adults with an age of 65 years or above

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fallers; Community dwelling older adults with an age above 65 years. A participant is categorized as faller in case of a history of ≥2 falls in the previous 12 months and with identified high fall risk on the TUG (i.e., completion time ≥13.5 seconds). A fall is defined as an event that results in a person coming to rest inadvertently on the ground/floor/other lower level (WHO, 2021). Asyncopal fall, identified through the report of a loss of consciousness during the fall, has a different etiology and therefore will not be counted as a fall (Ang et al., 2020).	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.; Diagnostic test: 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.; Diagnostic test: 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.; Other: 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).; Other: 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.
Non-Fallers; Community dwelling older adults with an age above 65 years. A participant is included as non-faller in case of a history of 0 falls in the previous 12 months and without an identified fall risk on the TUG test (i.e., completion time ≤13.5 seconds).	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.; Diagnostic test: 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.; Diagnostic test: 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.; Other: 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).; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatio-temporal parameters of gait	step length and width (cm)	baseline
Foot placement estimator	measure which estimates where the foot should be placed for stable gait	baseline
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
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
Fixation duration	Duration of fixation of the eyes on target, measured by the Hololens 2	baseline
Gain	Accuracy of the fixation of the eyes on target as measured by the Hololens 2	baseline
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multisensory integration	reaction times in visual/sensory vs. visuo-sensory conditions (ratio, in %) measured with CatchU app	baseline
Digit symbol substitution test	number of correct symbol-digit pairs completed	baseline
Trail making test	Time to complete part A vs. B (ratio in seconds)	baseline
Go/No Go test	Accuracy (number of correct responses)	baseline
Head Repositioning Accuracy	joint position error in degrees	baseline
Fly test	directional accuracy (in %) of movement	baseline
Fly test	Amplitude (in mm) of movement	baseline
vHIT	VOR-gain and VOR-gain asymmetry in %	baseline
fHIT	statfHIT (Static visual acuity): logMAR-score and dynfHIT (Dynamic visual acuity): % correct responses	baseline
Frailty	Fried criteria: Frailty level (categorical): non-frail (0/5), pre-frail( 1-2/5) or frail (≥3/5)	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	age in years	Screening before inclusion
Gender	male, female or other	Screening before inclusion
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
Fall history	number of falls in last 12 months	Screening before inclusion

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Principal Investigator: Ann Hallemans, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: older adults; Sensorimotor integration; visual tracking while walking
• Other Study ID Numbers: 6012 (Other)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No