Leg Length InequalityNCT03048656
The Postural Control in Individuals With the Structural Leg-length Discrepancy
A study testing static posturography in people with Leg Length Inequality, run by Poznan University of Medical Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Length Inequality
- What is being tested?
- static posturography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jan 2017to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- for patients: structural leg length discrepancy
- for healthy volunteers: symmetrical length of lower limbs
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Leg Length Inequality
- Being tested
- static posturography
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
static posturographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: static posturography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.02.2017
Secondary outcomes (1)
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].
Measured: 1.02.2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start18 Jan 2017
- Primary completion25 Jan 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Leg Length InequalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Małgorzata Eliks, Poznan University of Medical Sciences
- Investigators
- Przemysław Lisiński, PhD, Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048656
- Sponsor's protocol ID
- 418/14
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 4074116Murrell 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.
PubMed 1859258Sabharwal 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.
PubMed 18836788Lisinski 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.
PubMed 21963145Swaminathan 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.
PubMed 25082323Pajala 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.
PubMed 12959956Betsch 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.
PubMed 23479027Betsch 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.
PubMed 21769443Young 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.
PubMed 10802434Eliks 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.
PubMed 28793888
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Structural Leg-length Discrepancy Affect the Postural Control? Preliminary Study
- ClinicalTrials.gov ID
- NCT03048656
- Acronym / sponsor ID
- 418/14
- Conditions
- Leg Length Inequality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with leg-length discrepancy | Experimental | Other: static posturographyPatients 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. |
| control group | Active comparator | Other: static posturographyThe 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. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- for patients: structural leg length discrepancy
- for healthy volunteers: symmetrical length of lower limbs
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| static posturographyThe 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. | Other | Individuals with leg-length discrepancy, control group |
Primary outcome
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 secondary outcome
Evaluation of weight distribution during stance in subjects
Time frame: 1.02.2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 4074116Mahar 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.
- Background: PubMed 1859258Murrell 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.
- Background: PubMed 18836788Sabharwal 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.
- Background: PubMed 21963145Lisinski 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.
- Background: PubMed 25082323Swaminathan 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.
- Background: PubMed 12959956Pajala 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.
- Background: PubMed 23479027Betsch 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.
- Background: PubMed 21769443Betsch 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.
- Background: PubMed 10802434Young 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.
- Derived from this study: PubMed 28793888Eliks 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Przemysław Lisiński, PhD study director
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing static posturography in people with Leg Length Inequality, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects (time frame: 1.02.2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048656, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.