The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure

This study is currently recruiting participants.
Verified July 2011 by Rambam Health Care Campus
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01255241
First received: December 6, 2010
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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
Lower Limbs Deformities
Gait
Energy Expenditure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Lower Limb Deformities (LLD) on Children's Gait and on Energy Expenditure

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Initial status ambulation and Energy expenditure will be assessed upon enrolment, two to four months after surgery, and four months later.


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: August 2014
Groups/Cohorts
othopaedic surgical intervention
children with lower limbs deformities

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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Thirty patients will be recuited from primary care clinic

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255241

Contacts
Contact: Michael Zaidman, MD,PhD 972 50 206 4563 orthmz@gmail.com

Locations
Israel
Michael Zaidman Recruiting
Haifa, Israel, 31096
Contact: Michael Zaidman, MD, PhD    972502064563    orthmz@gmail.com   
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Michael Zaidman, MD Phd    972 50 2016 4563    orthmz@gmail.com   
Principal Investigator: Michael Zaidman, MDPhD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Michael Zaidman, MPhD Rambam Health Care Campus
Principal Investigator: Michael Zaidman, MD, PhD Rambam Medical Centre
  More Information

No publications provided

Responsible Party: Michael Zaidman, MD, PhD, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01255241     History of Changes
Other Study ID Numbers: 0518-10CTIL
Study First Received: December 6, 2010
Last Updated: July 28, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Lower Limbs Deformities
kinetics
kinematics
gait
energy expenditure

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014