Clinical trial NCT01255241: The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure
Official title: The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Limbs Deformities
Gait
Energy Expenditure
Keywords: Lower Limbs Deformities
kinetics
kinematics
gait
energy expenditure
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty patients will be recuited from primary care clinic

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male and female young patients, age ranging between six to eighteen years.
* Presenting

  * Lower limb mechanical axis deviation of 1.5 centimeters or more
  * Deviation of 5 degree or more from the normal values in the joint orientation angles

Exclusion Criteria:

* Patients presenting neurological and neuromuscular disorders, scoliosis, kyphosis, mental retardation, Lower Limb Deformity (LLD) more than 2 cm measured at x-ray.

Primary outcomes:
measure: 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
timeFrame: within four to six months after surgery and up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Michael Zaidman
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Michael Zaidman, MPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Medical Centre
name: Michael Zaidman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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