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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03048656
Other study ID # 418/14
Secondary ID
Status Completed
Phase N/A
First received February 6, 2017
Last updated February 8, 2017
Start date January 18, 2017
Est. completion date February 1, 2017

Study information

Verified date February 2017
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date February 1, 2017
Est. primary completion date January 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Poland Poznan University of Medical Sciences Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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]. 1.02.2017
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