- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03048656
The Postural Control in Individuals With the Structural Leg-length Discrepancy
Does the Structural Leg-length Discrepancy Affect the Postural Control? Preliminary Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Poznań, Poland, 61-701
- Poznan University of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1.02.2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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].
|
1.02.2017
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 418/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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