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The Postural Control in Individuals With the Structural Leg-length Discrepancy

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ClinicalTrials.gov Identifier: NCT03048656
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Małgorzata Eliks, Poznan University of Medical Sciences

Brief Summary:

The structural leg-length inequality caused by the shortening of a segment of an extremity, results in an altered position of lower limb joints, the pelvis and the spine in static as well as dynamic conditions. That may induce a disturbance of the postural control.

The objective of this study is to investigate the effect of the structural LLD on the control of the posture.


Condition or disease Intervention/treatment Phase
Leg Length Inequality Other: static posturography Not Applicable

Detailed Description:

The measurement of the weight distribution and the static posturography is performed on the balance platform Good Balance by Metitur . The device is comprised of the triangular force platform (800 mm x 800 mm x 800 mm) with electronic system and computer software. The body weight distribution is evaluated in the upright standing with eyes open, feet placed 20 cm from each other or narrower in children, with upper extremities in relaxed position by sides. The individual stands motionlessly for 15 s, then the measurement is recorded. The results of each lower extremity loading and a difference in weight bearing between extremities are expressed in percentages (%) .

The static posturography examination is performed with 3 various positions of feet, both with eyes open (EO) and eyes closed (EC). (1) Position : normal standing - an upright standing with feet placed parallel 20 cm apart. (2) Position: tandem - a stance with one foot placed ahead of the other, medial edge of feet was put on the midline of the balance platform. In the experimental group 2 trials were recorded: (a) foot of the shorter leg in the front, (b) foot of the shorter leg in the rear. In the control group also 2 trials are performed: (c) foot of the right leg in the front, (d) foot of the left leg in the front. (3) Position: one leg standing: stance on the one leg, foot placed 10 cm from midline of the platform, the other - 90 degrees flexion of the knee and the hip, test performed only with EO. Every participant is supposed to stand motionlessly for 30 s in normal standing , or for 20 s in tandem .and one leg standing position. Conditions of the posturographic examination involved : quiet and normally lit room , standing barefoot , the eyesight directed at a point in the distance of 2 m , glasses or contact lenses are worn if they are normally needed, arms held in the front of the body with hands together in order to limit movements of upper extremities . The recording is initiated when a stable position is attained . Each test is performed once .

Mean velocity (mm/s) of COP sway is measured as a quantitative parameter of the postural control assessment . Mean COP sway velocity is recorded both in anteroposterior (AP) and mediolateral (ML) directions .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Does the Structural Leg-length Discrepancy Affect the Postural Control? Preliminary Study
Actual Study Start Date : January 18, 2017
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individuals with leg-length discrepancy
Patients of Department of Paediatric Orthopaedics and Traumatology, Poznan University of Medical Sciences diagnosed with leg-length discrepancy. The examination of participants included a measurement of the length of lower limbs and the weight distribution as well as performing the static posturography.
Other: static posturography
The measurement of the weight distribution and the static posturography was performed on the balance platform Good Balance by Metitur . The device is comprised of the triangular force platform with electronic system and computer software. The body weight distribution was evaluated in the upright standing with eyes open, feet placed 20 cm from each other.The individual stood motionlessly for 15 s, then the measurement was recorded. The static posturography was performed with 3 various positions of feet, both with eyes open and eyes closed. (1) Position : normal standing - an upright standing with feet placed parallel 20 cm apart for 30 s. (2) Position: tandem - a stance with one foot placed ahead of the other. for 20 s. (3) Position: one leg standing: stance on the one leg for 20 s.

Active Comparator: control group
The group with healthy individuals; without leg-length discrepancy. The examination of participants included a measurement of the weight distribution as well as performing the static posturography.
Other: static posturography
The measurement of the weight distribution and the static posturography was performed on the balance platform Good Balance by Metitur . The device is comprised of the triangular force platform with electronic system and computer software. The body weight distribution was evaluated in the upright standing with eyes open, feet placed 20 cm from each other.The individual stood motionlessly for 15 s, then the measurement was recorded. The static posturography was performed with 3 various positions of feet, both with eyes open and eyes closed. (1) Position : normal standing - an upright standing with feet placed parallel 20 cm apart for 30 s. (2) Position: tandem - a stance with one foot placed ahead of the other. for 20 s. (3) Position: one leg standing: stance on the one leg for 20 s.




Primary Outcome Measures :
  1. Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects [ Time Frame: 1.02.2017 ]
    Mean COP velocity [mm/s] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant.


Secondary Outcome Measures :
  1. Evaluation of weight distribution during stance in subjects [ Time Frame: 1.02.2017 ]
    The weight loading of each limb is assessed in every participants. The result is expressed in kilograms [kg].



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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • for patients: structural leg length discrepancy
  • for healthy volunteers: symmetrical length of lower limbs

Exclusion Criteria:

  • for patients: achondroplasia, non-union, idiopathic scoliosis, extremity shortening in the course of neurological disease (e.g. Cerebral Palsy), vestibular disorder (e.g. Ménière's disease), diabetes, sensory disorder, intake of medications affecting psychomotor activity, dizziness, neurological diseases (e.g. epilepsy), BMI>30, using mobility aids (e.g. crutches)
  • for healthy volunteers: leg-length discrepancy, scoliosis, faulty posture, vestibular disorders, diabetes, intake of medications affecting psychomotor activity, dizziness, sensory disorders, neurological disease, BMI>30.

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): NCT03048656


Locations
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Poland
Poznan University of Medical Sciences
Poznań, Poland, 61-701
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
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Study Director: Przemysław Lisiński, PhD Poznan University of Medical Sciences

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Małgorzata Eliks, Assistant, MSc, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03048656     History of Changes
Other Study ID Numbers: 418/14
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Leg Length Inequality
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical