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Clinical Trials/NCT01803243
NCT01803243
Completed
N/A

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

University Children's Hospital Basel1 site in 1 country20 target enrollmentJuly 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Leg Length Inequality
Sponsor
University Children's Hospital Basel
Enrollment
20
Locations
1
Primary Endpoint
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Measuring spine dynamics is a necessity in order to better understand gait deviations throughout the whole body and to evaluate treatment effects on spinal movement during gait. However, 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 use an enhanced trunk marker set in order to evaluate the biomechanical effects of lower extremity treatments on spine dynamics in patients with different pathologies.

It has been hypothesized that

  1. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics during gait in patients with deviations occurring secondary to leg length inequality.
  2. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics during gait in patients that present both primary and secondary deviations such as seen in hemiplegic and diplegic cerebral palsy.
  3. treatment by means of either a shoe insole or a modified shoe with sole lift on the shorter side has an effect on spine dynamics during gait in patients with leg length inequality.
  4. treatment by means of an ankle foot orthosis to control the foot position has an effect on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.

To verify the hypotheses, instrumented gait analyses with a standard full body marker set and the enhanced trunk marker set will be carried out before and immediately after an orthotic lower extremity treatment in the respective patient group.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Reinald Brunner, MD

Doctor in Charge, Neuro-Orthopedics

University Children's Hospital Basel

Eligibility Criteria

Inclusion Criteria

  • Diagnosed structural leg length inequality (minimum 1% of body height)
  • Several different aetiologies (except neurological)
  • Able to walk a distance of minimum 50 meters without any assistive device

Exclusion Criteria

  • Leg length inequality due to neurological aetiology
  • Structural deformities of the spine
  • Obesity (\> 95th BMI-per-age percentile)
  • Injuries of the locomotor system which led to persistent deformities
  • Hemiplegic cerebral palsy patients:
  • Inclusion Criteria:
  • Diagnosed hemiplegic cerebral palsy (Gross Motor Function Classification System for Cerebral Palsy (GMFCS): Levels I and II)
  • Able to walk a distance of minimum 50 meters barefoot and without any assistive device
  • Exclusion Criteria:
  • Structural deformities of the spine

Outcomes

Primary Outcomes

Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.

Time Frame: Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after an orthotic treatment (both measurements within 1 hour).

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

Immediate changes in spinal kinematics in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.

Time Frame: Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour).

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

  • Immediate changes in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.(Data will be collected between April 2013 and June 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour).)

Study Sites (1)

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