Clinical trial NCT01803243: Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups
Official title: The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Length Inequality
Cerebral Palsy
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: Bern University of Applied Sciences
First posted: 2013-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Leg length inequality patients:

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
* Any previous surgical and casting treatments as well as botulinumtoxin treatments within preceding 6 months.
* Obesity (\> 95th BMI-per-age percentile)
* Injuries of the locomotor system which led to persistent deformities

Diplegic cerebral palsy patients:

Inclusion Criteria:

* Diagnosed diplegic 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
* Any previous surgical and casting treatments as well as botulinumtoxin treatments within preceding 6 months.
* Obesity (\> 95th BMI-per-age percentile)
* Injuries of the locomotor system which led to persistent deformities

Primary outcomes:
measure: Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.
timeFrame: 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).
measure: Immediate changes in spinal kinematics in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment.
timeFrame: 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).
Secondary outcomes:
measure: 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.
timeFrame: 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).
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
Study officials:
affiliation: University Children's Hospital Basel
name: Reinald Brunner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Federal Institute of Technology / Bern University of Applied Sciences
name: Stefan Schmid, PT, PhD
role: STUDY_CHAIR
affiliation: Swiss Federal Institute of Technology
name: Silvio Lorenzetti, PhD, DSc
role: STUDY_DIRECTOR
affiliation: University Children's Hospital Basel
name: Jacqueline Romkes, PhD
role: STUDY_DIRECTOR
References:
citation: Schmid S, Romkes J, Taylor WR, Lorenzetti S, Brunner R. Orthotic correction of lower limb function during gait does not immediately influence spinal kinematics in spastic hemiplegic cerebral palsy. Gait Posture. 2016 Sep;49:457-462. doi: 10.1016/j.gaitpost.2016.08.013. Epub 2016 Aug 12.