Clinical trial NCT01803256: Possibilities and Limitations of a New Method for the Measurement of Spine Dynamics During Gait
Official title: The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: Bern University of Applied Sciences
First posted: 2013-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scoliosis patients: Patients attending the Orthopedic Department at UKBB for scoliosis treatment.

Healthy controls: Middle and high school students in the Basel area.

Brief summary: The full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during gait in adolescents with and without structural spine deformities.

It has been hypothesized that the enhance trunk marker set:

1. is a valid method for the measurement of spine deformations in the sagittal, frontal and indirectly transverse planes.
2. is an applicable and reliable method for the measurement of spine dynamics during gait in healthy adolescents and in patients with structural deformities such as seen in scoliosis.
3. is sensitive enough to distinguish the spinal movement pattern during gait measured in scoliosis patients from the one measured in healthy adolescents.

To verify the hypotheses, the following measurements will be carried out:

* Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.
* Instrumented gait analysis with a standard full body marker set and the enhanced trunk marker set in scoliosis patients and healthy controls.


Eligibility criteria: Scoliosis patients:

Inclusion Criteria:

* Adolescent idiopathic scoliosis
* Able to walk a distance of minimum 50 meters barefoot and without any assistive device

Exclusion Criteria:

* Other types of scoliosis (e.g. of neurological origin)
* Previous treatment of scoliosis (conservative or surgery)
* Injuries of the locomotor system which led to persistent deformities

Healthy controls:

Exclusion Criteria:

* Any pathologies or diseases affecting the locomotor system
* Injuries to the locomotor system which led to persistent deformities
* Obesity (\> 95th BMI-per-age percentile)
* Leg length discrepancy (more than 1% of body height)

Primary outcomes:
measure: Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).
timeFrame: Data will be collected between April 2013 and June 2014. For each scoliosis patient, the radiographic measurements will be conducted immediately after inclusion and the motion analysis measurements within 48 hours of the radiographic measurements.
measure: Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in scoliosis patients and healthy adolescents during gait.
timeFrame: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
measure: Differences in spinal kinematics between scoliosis patients and healthy adolescents during gait.
timeFrame: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Secondary outcomes:
measure: Differences in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints between scoliosis patients and healthy adolescents during gait.
timeFrame: Data will be collected between April 2013 and June 2014. Parameters during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
Study officials:
affiliation: University Children's Hospital Basel
name: Reinald Brunner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Federal Institute of Technology / Bern University of Applied Sciences
name: Stefan Schmid, PT, PhD
role: STUDY_CHAIR
affiliation: Swiss Federal Institute of Technology
name: Silvio Lorenzetti, PhD, DSc
role: STUDY_DIRECTOR
affiliation: University Children's Hospital Basel
name: Jacqueline Romkes, PhD
role: STUDY_DIRECTOR
affiliation: University Children's Hospital Basel
name: Carol-Claudius Hasler, MD
role: STUDY_DIRECTOR
References:
citation: Schmid S, Studer D, Hasler CC, Romkes J, Taylor WR, Brunner R, Lorenzetti S. Using Skin Markers for Spinal Curvature Quantification in Main Thoracic Adolescent Idiopathic Scoliosis: An Explorative Radiographic Study. PLoS One. 2015 Aug 13;10(8):e0135689. doi: 10.1371/journal.pone.0135689. eCollection 2015.
citation: Schmid S, Studer D, Hasler CC, Romkes J, Taylor WR, Lorenzetti S, Brunner R. Quantifying spinal gait kinematics using an enhanced optical motion capture approach in adolescent idiopathic scoliosis. Gait Posture. 2016 Feb;44:231-7. doi: 10.1016/j.gaitpost.2015.12.036. Epub 2015 Dec 29.