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

This study is currently recruiting participants.
Verified April 2013 by University Children's Hospital Basel
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
Bern University of Applied Sciences
Information provided by (Responsible Party):
Prof. Reinald Brunner, MD, University Children's Hospital Basel
ClinicalTrials.gov Identifier:
NCT01803256
First received: February 26, 2013
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.

Condition
Scoliosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies

Resource links provided by NLM:


Further study details as provided by University Children's Hospital Basel:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.

  • 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. ] [ Designated as safety issue: No ]
    Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Scoliosis patients:
15 patients with adolescent idiopathic scoliosis.
Control subjects:
15 adolescent healthy control subjects

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803256

Contacts
Contact: Stefan Schmid, PT, MA +41318483796 stefanschmid79@gmail.com

Locations
Switzerland
University Children's Hospital Basel Recruiting
Basel, Switzerland, 4056
Contact: Reinald Brunner, MD    +41617041802    reinaldbrunner@sunrise.ch   
Principal Investigator: Reinald Brunner, MD         
Sponsors and Collaborators
University Children's Hospital Basel
Swiss Federal Institute of Technology
Bern University of Applied Sciences
Investigators
Principal Investigator: Reinald Brunner, MD University Children's Hospital Basel
Study Chair: Stefan Schmid, PT, MA Swiss Federal Institute of Technology / Bern University of Applied Sciences
Study Director: Silvio Lorenzetti, PhD, ScD 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
  More Information

Publications:
Responsible Party: Prof. Reinald Brunner, MD, Doctor in Charge, Neuro-Orthopedics, University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT01803256     History of Changes
Other Study ID Numbers: UKBB-Spine-1315-1
Study First Received: February 26, 2013
Last Updated: April 17, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 21, 2014