NCT03048656

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

7 days

First QC Date

February 6, 2017

Last Update Submit

February 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1.02.2017

Secondary Outcomes (1)

  • Evaluation of weight distribution during stance in subjects

    1.02.2017

Study Arms (2)

Individuals with leg-length discrepancy

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

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.

Individuals with leg-length discrepancycontrol group

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 61-701, Poland

Location

Related Publications (10)

  • 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.

    PMID: 4074116BACKGROUND
  • 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.

    PMID: 1859258BACKGROUND
  • 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.

    PMID: 18836788BACKGROUND
  • 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.

    PMID: 21963145BACKGROUND
  • 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.

    PMID: 25082323BACKGROUND
  • 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.

    PMID: 12959956BACKGROUND
  • 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.

    PMID: 23479027BACKGROUND
  • 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.

    PMID: 21769443BACKGROUND
  • 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.

    PMID: 10802434BACKGROUND
  • 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.

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Przemysław Lisiński, PhD

    Poznan University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant, MSc

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 9, 2017

Study Start

January 18, 2017

Primary Completion

January 25, 2017

Study Completion

February 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations