Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups

Study Overview
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Brief Summary
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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 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. 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. 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. 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.

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

Conditions
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Leg Length Inequality, Cerebral Palsy

Intervention / Treatment
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* Other: Ankle foot orthosis
* Other: Shoe insole
* Other: Modified shoe with sole lift


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leg length correction<br>The shorter leg in a sample of 15 patients with structural leg length inequality will be corrected by either a shoe insole or a modified shoe with sole lift. | Other: Shoe insole<br>* The heel of the shorter leg of the patient is lifted by a shoe insole. This procedure is commonly applied with leg length differences of up to 20mm.<br>Other: Modified shoe with sole lift<br>* The heel of the shorter leg of the patient is lifted by building up the sole of the shoe (shoe sole lift). This procedure is commonly applied with leg length differences of 20mm and more.<br>|
| Experimental: Control of foot position 1<br>The foot position in in a sample of 15 patients with hemiplegic cerebral palsy will be controlled by an ankle foot orthosis. | Other: Ankle foot orthosis<br>* Ankle foot orthoses are a common treatment method to control the foot position during walking and to prevent ankle plantar flexion contractures in cerebral palsy patients.<br>|
| Experimental: Control of foot position 2<br>The foot position in in a sample of 15 patients with diplegic cerebral palsy will be controlled by an ankle foot orthosis. | Other: Ankle foot orthosis<br>* Ankle foot orthoses are a common treatment method to control the foot position during walking and to prevent ankle plantar flexion contractures in cerebral palsy patients.<br>|
| No Intervention: Control<br>A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy 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 2015. Each patient will be measured before and immediately after an orthotic treatment (both measurements within 1 hour). | 
| Immediate changes in spinal kinematics in patients with leg length inequality and cerebral palsy during gait following an orthotic lower extremity treatment. | 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 2015. Each patient will be measured before and immediately after the orthotic treatment (both measurements within 1 hour). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). |