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Standing Balance Control Across the Lifespan (BaCoMech)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050774
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Pieter Meyns, Hasselt University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Children, Adult Device: Balance boards Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Balance Control Mechanisms During Perturbed Standing Across the Lifespan
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Arm Intervention/treatment
Experimental: Age group 1
6-9 years old
Device: Balance boards
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

Experimental: Age group 2
15-17 years old
Device: Balance boards
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

Experimental: Age group 3
18 - 24 years old
Device: Balance boards
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

Experimental: Age group 4
65-80 years old
Device: Balance boards
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




Primary Outcome Measures :
  1. 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.)

  2. 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.)

  3. 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.))



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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  1. inability to speak and understand Dutch;
  2. inability to maintain independent unsupported stance for 60 seconds;
  3. current diagnosis of neurological or sensory disorders;
  4. recurrent dizziness;
  5. obesity ;
  6. a history of orthopaedic disorders;
  7. surgical operation of the lower extremity during last two years;
  8. use of drugs affecting the CNS or known to affect balance control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050774


Contacts
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Contact: Pieter Meyns, prof. dr. +32 11 26 93 95 pieter.meyns@uhasselt.be
Contact: Maud Van Den Bogaart, drs. +32 11 26 93 28 maud.vandenbogaart@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Hasselt, Belgium, 3500
Contact: Maud Van Den Bogaart, drs.    +32 11 26 93 28    maud.vandenbogaart@uhasselt.be   
Sponsors and Collaborators
Hasselt University
VU University of Amsterdam

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Responsible Party: Pieter Meyns, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04050774    
Other Study ID Numbers: Projectlifespanbalance2018-001
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No