The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure (LLD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01255241|
Recruitment Status : Unknown
Verified July 2011 by Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : December 7, 2010
Last Update Posted : July 29, 2011
Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result from various conditions such as trauma, tumors, infection, and dysplasia, congenital and metabolic abnormalities. It is assumed that correction of deformities by surgical procedure will improve ambulation and reduce energy expenditure.
This prospective study will document the process of establishing the initial localization and magnitude of deformity through physical and radiological examination, kinetic and kinematical parameters, and measuring energy expenditure. The study will also document the type of surgical intervention undertaken to correct the deformity. Following a recovery from surgery, children's ambulation will be assessed again, by physical and radiological examination, by kinetic and kinematical parameters, and by measuring energy expenditure. A third series of exams will be performed four months later.
It is expected that the surgical intervention will improve ambulation and reduce energy expenditure. This study aims at establishing a model enabling to assess ambulation and energy expenditure before and after surgical intervention. The results of the study may have practical implications on the decision and type of surgical procedures.
|Condition or disease|
|Lower Limbs Deformities Gait Energy Expenditure|
Thirty patients, age ranging between six to eighteen years will be studied by kinetic and kinematic parameter to assess the initial status ambulation. Energy expenditure will be measured by metabolic monitoring. Patients will undergo the needed surgical intervention and their ambulation will be re-assessed by the same parameters upon recovery, and four months later on. All patients /or their parents will sign and informed consent form.
Patients with LLDF will be subdivided according to the anatomic localization of deformity (proximal femur, distal femur, femoral shaft, proximal tibia, distal tibia, tibial shaft, combined complex deformity) and the deformity plane (frontal, sagittal, axial, and oblique). The patients will undergo a complete physical routine examination. The deformity plane, localization and magnitude will be defined by radiological measurements and by physical examination. Rotational profile will be determined by physical examination.
Patients meeting the inclusion criteria will undergo a first gait analysis. Patients will walk on a flat floor, to establish locomotion base line, assess joint range of motions (ROM) during ambulation (kinematics), and recording of moments and powers of the joints (kinetics).
While walking on the flat floor, a first measurement of energy expenditure will be made. Subsequently children will walk on a treadmill while they are connected to the metabolic monitor.
Patients will undergo the required type of surgical correction of the deformity.
Following recovery , including regaining of range of motion (ROM), and antalgic gait, patients will undergo the second gait analysis and Energy expenditure measurements, which will be schedule two to four months after the surgery and according to the type od surgical intervention. The third gait lab and energy expenditure exams will be performed four month afterwards. The results will be analyzed and compared to those obtained prior to the intervention. The overall time for the study is planned for 24 months. Results will be analyzed by ANOVA and post hoc tests.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure|
|Study Start Date :||February 2011|
|Estimated Study Completion Date :||August 2014|
othopaedic surgical intervention
children with lower limbs deformities
- Lower limbs deformities defined as (a) lower limb mechanical axis deviation of 1.5 centimeters or more(b) Deviation of 5 degree or more from the normal values in the joint orientation angles [ Time Frame: within four to six months after surgery and up to one year ]Initial status ambulation and Energy expenditure will be assessed upon enrolment, two to four months after surgery, and four months later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255241
|Contact: Michael Zaidman, MD,PhD||972 50 206 firstname.lastname@example.org|
|Haifa, Israel, 31096|
|Contact: Michael Zaidman, MD, PhD 972502064563 email@example.com|
|Rambam Medical Center||Recruiting|
|Haifa, Israel, 31096|
|Contact: Michael Zaidman, MD Phd 972 50 2016 4563 firstname.lastname@example.org|
|Principal Investigator: Michael Zaidman, MDPhD|
|Principal Investigator:||Michael Zaidman, MPhD||Rambam Health Care Campus|
|Principal Investigator:||Michael Zaidman, MD, PhD||Rambam Medical Centre|