Children, AdultBaCoMechNCT04050774
Standing Balance Control Across the Lifespan
A study testing Balance boards in people with Children, Adult, run by Hasselt University at 1 site in Belgium.
Trial summary
Falls are the leading cause of nonfatal injuries in children and elderly. To understand the causes of falling in these populations, fundamental knowledge of how ageing affects balance control is of utmost importance. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Adult
- What is being tested?
- Balance boards
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Nov 2018to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- prepubertal children (6-9y)
- postpubertal children (15-18y)
- young adults (18-24y)
- healthy non-falling older adults (65-80y) will be included if they 1) did not experience two or more falls during normal daily activities in the preceding year and 2) have no cognitive impairment (tested with Mini-Mental state examination).
Who cannot join
- inability to speak and understand Dutch;
- inability to maintain independent unsupported stance for 60 seconds;
- current diagnosis of neurological or sensory disorders;
- recurrent dizziness;
- obesity ;
- a history of orthopaedic disorders;
- surgical operation of the lower extremity during last two years;
- use of drugs affecting the CNS or known to affect balance control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Control Mechanisms During Perturbed Standing Across the Lifespan
Falls are the leading cause of nonfatal injuries in children and elderly. To understand the causes of falling in these populations, fundamental knowledge of how ageing affects balance control is of utmost importance.
In general, two biomechanical mechanisms allow people to control balance; 1.moving the center of pressure within the base of support using ankle muscle activation; 2.counter-rotating segments around the center of mass. To understand how balance is controlled differently across the lifespan, 4 age groups (each N=20) will be compared to each other; i.e. prepubertal children (6-9y), postpubertal children (15-17y), young adults (18-24y), healthy non-falling older adults (65-80y). .
A force plate platform combined with 3D movement registration will be used to determine the biomechanical balance control strategy across the lifespan during unperturbed and perturbed standing. The innovative but focused scope of this study could provide a breakthrough in our biomechanical understanding of balance control and, in particular, the changes in limitations of balance control in childhood and an ageing (fall-prone) population. The gained fundamental knowledge could lead to unprecedented insights in the causes of falling across the lifespan and in possible targets for intervention.
- Conditions
- Children, Adult
- Being tested
- Balance boards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance boardsDevice
The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane. The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively). The radius of the cylinder will kept constant at 24 cm. The standing surface will be 48cm x 48 cm
| Study group | Role | What they receive |
|---|---|---|
| Age group 1 | Experimental | 6-9 years old Receives: Device: Balance boards |
| Age group 2 | Experimental | 15-17 years old Receives: Device: Balance boards |
| Age group 3 | Experimental | 18 - 24 years old Receives: Device: Balance boards |
| Age group 4 | Experimental | 65-80 years old Receives: Device: Balance boards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Control; centre of mass acceleration based on 3D movement registration and ground reaction forces
Centre of mass acceleration (in kg.m2/s2) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS. Learning to balance on one leg: motor strategy and sensory weighting. J Neurophysiol. 2015;114(5):2967-82.)
Measured: day 1
Contribution of the ankle strategy to centre of mass acceleration based on 3D movement registration and ground reaction forces
The contribution of the ankle strategy (difference between the centre of pressure and the centre of mass (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS. Learning to balance on one leg: motor strategy and sensory weighting. J Neurophysiol. 2015;114(5):2967-82.)
Measured: day 1
Contribution of the counter-rotation mechanism to centre of mass acceleration based on 3D movement registration and ground reaction forces
The contribution of the counter-rotation mechanism (change in angular momentum (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS. Learning to balance on one leg: motor strategy and sensory weighting. J Neurophysiol. 2015;114(5):2967-82.))
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start21 Nov 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, AdultStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Principal investigator, Pieter Meyns, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050774
- Sponsor's protocol ID
- Projectlifespanbalance2018-001
- Acronym
- BaCoMech
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Control Mechanisms During Perturbed Standing Across the Lifespan
- ClinicalTrials.gov ID
- NCT04050774
- Acronym / sponsor ID
- BaCoMech / Projectlifespanbalance2018-001
- Conditions
- Children, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 8 Aug 2019 (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.
Falls are the leading cause of nonfatal injuries in children and elderly. To understand the causes of falling in these populations, fundamental knowledge of how ageing affects balance control is of utmost importance.
In general, two biomechanical mechanisms allow people to control balance; 1.moving the center of pressure within the base of support using ankle muscle activation; 2.counter-rotating segments around the center of mass. To understand how balance is controlled differently across the lifespan, 4 age groups (each N=20) will be compared to each other; i.e. prepubertal children (6-9y), postpubertal children (15-17y), young adults (18-24y), healthy non-falling older adults (65-80y). .
A force plate platform combined with 3D movement registration will be used to determine the biomechanical balance control strategy across the lifespan during unperturbed and perturbed standing. The innovative but focused scope of this study could provide a breakthrough in our biomechanical understanding of balance control and, in particular, the changes in limitations of balance control in childhood and an ageing (fall-prone) population. The gained fundamental knowledge could lead to unprecedented insights in the causes of falling across the lifespan and in possible targets for intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Age group 1 | Experimental | Device: Balance boards6-9 years old |
| Age group 2 | Experimental | Device: Balance boards15-17 years old |
| Age group 3 | Experimental | Device: Balance boards18 - 24 years old |
| Age group 4 | Experimental | Device: Balance boards65-80 years old |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- prepubertal children (6-9y)
- postpubertal children (15-18y)
- young adults (18-24y)
- healthy non-falling older adults (65-80y) will be included if they 1) did not experience two or more falls during normal daily activities in the preceding year and 2) have no cognitive impairment (tested with Mini-Mental state examination).
Key exclusion criteria (8 listed)
- inability to speak and understand Dutch;
- inability to maintain independent unsupported stance for 60 seconds;
- current diagnosis of neurological or sensory disorders;
- recurrent dizziness;
- obesity ;
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 |
|---|---|---|
| Balance boardsThe unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane. The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively). The radius of the cylinder will kept constant at 24 cm. The standing surface will be 48cm x 48 cm | Device | Age group 1, Age group 2, Age group 3, Age group 4 |
Primary outcome
Balance Control; centre of mass acceleration based on 3D movement registration and ground reaction forces
Time frame: day 1
Centre of mass acceleration (in kg.m2/s2) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS. Learning to balance on one leg: motor strategy and sensory weighting. J Neurophysiol. 2015;114(5):2967-82.)
Contribution of the ankle strategy to centre of mass acceleration based on 3D movement registration and ground reaction forces
Time frame: day 1
The contribution of the ankle strategy (difference between the centre of pressure and the centre of mass (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS. Learning to balance on one leg: motor strategy and sensory weighting. J Neurophysiol. 2015;114(5):2967-82.)
Contribution of the counter-rotation mechanism to centre of mass acceleration based on 3D movement registration and ground reaction forces
Time frame: day 1
The contribution of the counter-rotation mechanism (change in angular momentum (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS. Learning to balance on one leg: motor strategy and sensory weighting. J Neurophysiol. 2015;114(5):2967-82.))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance boards in people with Children, Adult, run by Hasselt University 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Control; centre of mass acceleration based on 3D movement registration and ground reaction forces (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.