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NCT Number: NCT01803256

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

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).

    Time frame: 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.

    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.

  2. Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in scoliosis patients and healthy adolescents during gait.

    Time frame: 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.

    Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.

  3. Differences in spinal kinematics between scoliosis patients and healthy adolescents during gait.

    Time frame: 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.

    Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.

Secondary outcomes

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

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Collaborators

  • Bern University of Applied Sciences
  • Swiss Federal Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Mar 4, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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