The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
A sample of 15 healthy controls from a simultaneously conducted study (UKBB-Spine-1315-1) will be used for comparative purposes.
Control of foot position 2
The foot position in in a sample of 15 patients with diplegic cerebral palsy will be controlled by an ankle foot orthosis.
干预措施: Ankle foot orthosis (Other)
Leg length correction
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.
干预措施: Shoe insole (Other)
Leg length correction
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.
干预措施: Modified shoe with sole lift (Other)
Control of foot position 1
The foot position in in a sample of 15 patients with hemiplegic cerebral palsy will be controlled by an ankle foot orthosis.
干预措施: Ankle foot orthosis (Other)
结局指标
主要结局
Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in patients with leg length inequality and cerebral palsy during gait.
时间窗: 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.
时间窗: 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.
次要结局
- 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).)
研究者
Prof. Reinald Brunner, MD
Doctor in Charge, Neuro-Orthopedics
University Children's Hospital Basel