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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 : February 11, 2020
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Pieter Meyns, Hasselt University

Tracking Information
First Submitted Date  ICMJE August 5, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE November 21, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
  • 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.))
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
Balance Control including ankle strategy and counter-rotation mechanism 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 center of mass) and the counter-rotation mechanism (change in angular momentum) to center 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.)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standing Balance Control Across the Lifespan
Official Title  ICMJE Balance Control Mechanisms During Perturbed Standing Across the Lifespan
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Children, Adult
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Age group 1
    6-9 years old
    Intervention: Device: Balance boards
  • Experimental: Age group 2
    15-17 years old
    Intervention: Device: Balance boards
  • Experimental: Age group 3
    18 - 24 years old
    Intervention: Device: Balance boards
  • Experimental: Age group 4
    65-80 years old
    Intervention: Device: Balance boards
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04050774
Other Study ID Numbers  ICMJE Projectlifespanbalance2018-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pieter Meyns, Hasselt University
Study Sponsor  ICMJE Hasselt University
Collaborators  ICMJE VU University of Amsterdam
Investigators  ICMJE Not Provided
PRS Account Hasselt University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP