Possibilities and Limitations of a New Method for the Measurement of Spine Dynamics During Gait

Scoliosis Clinical Trial

Official title:

The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803256
• Other study ID #: UKBB-Spine-1315-1
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: November 25, 2016
• Start date: April 2013
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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)

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Children's Hospital Basel	Bern University of Applied Sciences, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).	This primary endpoint will only be evaluated in scoliosis patients since healthy adolescents do not undergo radiographic measurements. Parameters include lumbar and thoracic spine curvature angles in the sagittal and frontal planes.	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.	No
Primary	Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in scoliosis patients and healthy adolescents during gait.	Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.	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.	No
Primary	Differences in spinal kinematics between scoliosis patients and healthy adolescents during gait.	Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.	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.	No
Secondary	Differences in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints between scoliosis patients and healthy adolescents during gait.	Parameters include gait speed, cadence and single and double limb support as well as angles, torques and powers of peripheral joints in all three planes.	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.	No