The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies
Shoe insole
+ Modified shoe with sole lift
+ Ankle foot orthosis
Bone Diseases+8
+ Bone Diseases, Developmental
+ Brain Damage, Chronic
Treatment Study
Summary
Study start date: July 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University Children's Hospital Basel
Basel, SwitzerlandOpen University Children's Hospital Basel in Google Maps