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

Primary Purpose

Leg Length Inequality

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
static posturography
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Leg Length Inequality

Eligibility Criteria

6 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Poznan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individuals with leg-length discrepancy

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects
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

Evaluation of weight distribution during stance in subjects
The weight loading of each limb is assessed in every participants. The result is expressed in kilograms [kg].

Full Information

First Posted
February 6, 2017
Last Updated
February 8, 2017
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03048656
Brief Title
The Postural Control in Individuals With the Structural Leg-length Discrepancy
Official Title
Does the Structural Leg-length Discrepancy Affect the Postural Control? Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
January 25, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Inequality

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individuals with leg-length discrepancy
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
static posturography
Intervention Description
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 Measure Information:
Title
Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects
Description
Mean COP velocity [mm/s] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant.
Time Frame
1.02.2017
Secondary Outcome Measure Information:
Title
Evaluation of weight distribution during stance in subjects
Description
The weight loading of each limb is assessed in every participants. The result is expressed in kilograms [kg].
Time Frame
1.02.2017

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Przemysław Lisiński, PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznań
ZIP/Postal Code
61-701
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
4074116
Citation
Mahar RK, Kirby RL, MacLeod DA. Simulated leg-length discrepancy: its effect on mean center-of-pressure position and postural sway. Arch Phys Med Rehabil. 1985 Dec;66(12):822-4.
Results Reference
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PubMed Identifier
1859258
Citation
Murrell P, Cornwall MW, Doucet SK. Leg-length discrepancy: effect on the amplitude of postural sway. Arch Phys Med Rehabil. 1991 Aug;72(9):646-8.
Results Reference
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PubMed Identifier
18836788
Citation
Sabharwal S, Kumar A. Methods for assessing leg length discrepancy. Clin Orthop Relat Res. 2008 Dec;466(12):2910-22. doi: 10.1007/s11999-008-0524-9. Epub 2008 Oct 4.
Results Reference
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PubMed Identifier
21963145
Citation
Lisinski P, Huber J, Gajewska E, Szlapinski P. The body balance training effect on improvement of motor functions in paretic extremities in patients after stroke. A randomized, single blinded trial. Clin Neurol Neurosurg. 2012 Jan;114(1):31-6. doi: 10.1016/j.clineuro.2011.09.002. Epub 2011 Oct 2.
Results Reference
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PubMed Identifier
25082323
Citation
Swaminathan V, Cartwright-Terry M, Moorehead JD, Bowey A, Scott SJ. The effect of leg length discrepancy upon load distribution in the static phase (standing). Gait Posture. 2014 Sep;40(4):561-3. doi: 10.1016/j.gaitpost.2014.06.020. Epub 2014 Jul 17.
Results Reference
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PubMed Identifier
12959956
Citation
Pajala S, Era P, Koskenvuo M, Kaprio J, Tolvanen A, Heikkinen E, Tiainen K, Rantanen T. Contribution of genetic and environmental effects to postural balance in older female twins. J Appl Physiol (1985). 2004 Jan;96(1):308-15. doi: 10.1152/japplphysiol.00660.2003. Epub 2003 Sep 5.
Results Reference
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PubMed Identifier
23479027
Citation
Betsch M, Rapp W, Przibylla A, Jungbluth P, Hakimi M, Schneppendahl J, Thelen S, Wild M. Determination of the amount of leg length inequality that alters spinal posture in healthy subjects using rasterstereography. Eur Spine J. 2013 Jun;22(6):1354-61. doi: 10.1007/s00586-013-2720-x. Epub 2013 Mar 13.
Results Reference
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PubMed Identifier
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Citation
Betsch M, Wild M, Grosse B, Rapp W, Horstmann T. The effect of simulating leg length inequality on spinal posture and pelvic position: a dynamic rasterstereographic analysis. Eur Spine J. 2012 Apr;21(4):691-7. doi: 10.1007/s00586-011-1912-5. Epub 2011 Jul 17.
Results Reference
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PubMed Identifier
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Citation
Young RS, Andrew PD, Cummings GS. Effect of simulating leg length inequality on pelvic torsion and trunk mobility. Gait Posture. 2000 Jun;11(3):217-23. doi: 10.1016/s0966-6362(00)00048-5.
Results Reference
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PubMed Identifier
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Citation
Eliks M, Ostiak-Tomaszewska W, Lisinski P, Koczewski P. Does structural leg-length discrepancy affect postural control? Preliminary study. BMC Musculoskelet Disord. 2017 Aug 9;18(1):346. doi: 10.1186/s12891-017-1707-x.
Results Reference
derived

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

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