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

NCT01803256 | Completed

• 1 other identifier: UKBB-Spine-1315-1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Secondary Outcomes (1)

• Differences in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints between scoliosis patients and healthy adolescents during gait.

  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.

Study Arms (2)

Scoliosis patients:

15 patients with adolescent idiopathic scoliosis.

Control subjects:

15 adolescent healthy control subjects

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Swiss Federal Institute of Technology: collaborator
• Bern University of Applied Sciences: collaborator

Study Sites (1)

University Children's Hospital Basel

Basel, 4056, Switzerland

Location

Related 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. doi: 10.1371/journal.pone.0135689. eCollection 2015.

  PMID: 26270557 RESULT

• 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.

  PMID: 27004664 RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Reinald Brunner, MD

  University Children's Hospital Basel

  PRINCIPAL INVESTIGATOR

• Stefan Schmid, PT, PhD

  Swiss Federal Institute of Technology / Bern University of Applied Sciences

  STUDY CHAIR

• Silvio Lorenzetti, PhD, DSc

  Swiss Federal Institute of Technology

  STUDY DIRECTOR

• Jacqueline Romkes, PhD

  University Children's Hospital Basel

  STUDY DIRECTOR

• Carol-Claudius Hasler, MD

  University Children's Hospital Basel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Charge, Neuro-Orthopedics

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

CH (1)