The Effect of Lower Limb Deformities (LLD) on Children's Gait and on 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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
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
Initial status ambulation and Energy expenditure will be assessed upon enrolment, two to four months after surgery, and four months later.
within four to six months after surgery and up to one year
No
Michael Zaidman, MPhD
Principal Investigator
Rambam Health Care Campus
Israel: Ministry of Health
0518-10CTIL
NCT01255241
February 2011
August 2014
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