NCT04050774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

2.4 years

First QC Date

August 5, 2019

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.)

    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.)

    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.))

    day 1

Study Arms (4)

Age group 1

EXPERIMENTAL

6-9 years old

Device: Balance boards

Age group 2

EXPERIMENTAL

15-17 years old

Device: Balance boards

Age group 3

EXPERIMENTAL

18 - 24 years old

Device: Balance boards

Age group 4

EXPERIMENTAL

65-80 years old

Device: Balance boards

Interventions

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

Age group 1Age group 2Age group 3Age group 4

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 8, 2019

Study Start

November 21, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations