AgedBALANCARNCT06345625
Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults
An observational study of Aged and Accidental Fall, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged, Accidental Fall, Postural Balance
- What is being tested?
- Cognition, Sensory function and Frailty
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2024to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community dwelling older adults with an age of 65 years or above
Who may be able to join
- Community dwelling
- an age of 65 years or above
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eugénie Lambrecht, MSc, PT contact
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp
Antwerp, 2160
Ann Hallemans, PhD, +32 3 265 29 12, ann.hallemans@uantwerpen.be
PhD
About this study
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
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.
Read the 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.
- Conditions
- Aged, Accidental Fall, Postural Balance, Gait
- Being tested
- Cognition, Sensory function, Frailty, Biomechanical movement analysis, Screening
- Keywords
- older adults, Sensorimotor integration, visual tracking while walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CognitionDiagnostic test
- 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 functionDiagnostic test
- 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.
FrailtyDiagnostic test
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).
Biomechanical movement analysisOther
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.
ScreeningOther
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 upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Cognition; Diagnostic Test: Sensory function; Diagnostic Test: Frailty; Other: Biomechanical movement analysis; Other: Screening; Other: Follow up | |
| 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). Receives: Diagnostic Test: Cognition; Diagnostic Test: Sensory function; Diagnostic Test: Frailty; Other: Biomechanical movement analysis; Other: Screening; Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatio-temporal parameters of gait
step length and width (cm)
Measured: baseline
Foot placement estimator
measure which estimates where the foot should be placed for stable gait
Measured: 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)
Measured: 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)
Measured: baseline
Fixation duration
Duration of fixation of the eyes on target, measured by the Hololens 2
Measured: baseline
Gain
Accuracy of the fixation of the eyes on target as measured by the Hololens 2
Measured: 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.
Measured: 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.
Measured: monthly during 12 months of follow-up
Secondary outcomes (10)
Multisensory integration
reaction times in visual/sensory vs. visuo-sensory conditions (ratio, in %) measured with CatchU app
Measured: baseline
Digit symbol substitution test
number of correct symbol-digit pairs completed
Measured: baseline
Trail making test
Time to complete part A vs. B (ratio in seconds)
Measured: baseline
Go/No Go test
Accuracy (number of correct responses)
Measured: baseline
Head Repositioning Accuracy
joint position error in degrees
Measured: baseline
Fly test
directional accuracy (in %) of movement
Measured: baseline
Fly test
Amplitude (in mm) of movement
Measured: baseline
vHIT
VOR-gain and VOR-gain asymmetry in %
Measured: baseline
fHIT
statfHIT (Static visual acuity): logMAR-score and dynfHIT (Dynamic visual acuity): % correct responses
Measured: baseline
Frailty
Fried criteria: Frailty level (categorical): non-frail (0/5), pre-frail( 1-2/5) or frail (≥3/5)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start7 May 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Hallemans, Universiteit Antwerpen
- Investigators
- Ann Hallemans, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345625
- Sponsor's protocol ID
- 6012
- Acronym
- BALANCAR
- Status last verified
- May 2024
- First submitted
- 5 Mar 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lambrecht E, Embrechts E, Beckwee D, Vereeck L, Hallemans A, De Hertogh W. The influence of sensory function on walking stability in aging and falls through a head-movement perturbation model. Geroscience. 2026 Oct 19. doi: 10.1007/s11357-026-02602-3. Online ahead of print.
PubMed 42895590
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06345625
- Acronym / sponsor ID
- BALANCAR / 6012
- Conditions
- Aged, Accidental Fall, Postural Balance, Gait
- Keywords
- older adults, Sensorimotor integration, visual tracking while walking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallers | – | Diagnostic Test: Cognition, Diagnostic Test: Sensory function, Diagnostic Test: Frailty, Other: Biomechanical movement analysis, Other: Screening, Other: Follow upCommunity 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). |
| Non-Fallers | – | Diagnostic Test: Cognition, Diagnostic Test: Sensory function, Diagnostic Test: Frailty, Other: Biomechanical movement analysis, Other: Screening, Other: Follow upCommunity 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). |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community dwelling older adults with an age of 65 years or above
Key inclusion criteria (2 listed)
- Community dwelling
- an age of 65 years or above
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognition1. 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. | Diagnostic test | Fallers, Non-Fallers |
| Sensory function1. 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. | Diagnostic test | Fallers, Non-Fallers |
| FrailtyFrailty 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). | Diagnostic test | Fallers, Non-Fallers |
| Biomechanical movement analysisMarkers 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 | Fallers, Non-Fallers |
| ScreeningThe 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). | Other | Fallers, Non-Fallers |
| Follow upParticipants 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. | Other | Fallers, Non-Fallers |
Primary outcome
Spatio-temporal parameters of gait
Time frame: baseline
step length and width (cm)
Foot placement estimator
Time frame: baseline
measure which estimates where the foot should be placed for stable gait
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)
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)
Fixation duration
Time frame: baseline
Duration of fixation of the eyes on target, measured by the Hololens 2
Gain
Time frame: baseline
Accuracy of the fixation of the eyes on target as measured by the Hololens 2
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.
10 secondary outcomes
Multisensory integration
Time frame: baseline
Digit symbol substitution test
Time frame: baseline
Trail making test
Time frame: baseline
Go/No Go test
Time frame: baseline
Head Repositioning Accuracy
Time frame: baseline
Fly test
Time frame: baseline
Fly test
Time frame: baseline
vHIT
Time frame: baseline
fHIT
Time frame: baseline
Frailty
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 42895590Lambrecht E, Embrechts E, Beckwee D, Vereeck L, Hallemans A, De Hertogh W. The influence of sensory function on walking stability in aging and falls through a head-movement perturbation model. Geroscience. 2026 Oct 19. doi: 10.1007/s11357-026-02602-3. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugénie Lambrecht, MSc, PT contact
Ann Hallemans principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged and Accidental Fall, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Hallemans, PhD (032652912, ann.hallemans@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatio-temporal parameters of gait (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.