Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624280
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Does Orthopedic Surgery Improve Gait Efficiency in Children With Cerebral Palsy A Retrospective Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does Orthopedic Surgery Improve Gait Efficiency in Children With Cerebral Palsy A Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OrthoSurg01
Brief Summary:
Purpose The aim of this retrospective observational study is to describe the demographic clinical and functional characteristics of children and adolescents with spastic cerebral palsy CP undergoing Single Event Multilevel Surgery SEMLS and changes in their gait efficiency following surgery
Methods Seventy-eight participants were included and a total of eighty-four SEMLS analyzed All the participants were followed by the Children Rehabilitation Unit of the Local Health Authority of Reggio Emilia Participants met the following requirements age 4-20 years hemiplegic or diplegic CP Gross Motor Function Classification System level I II or III 3D gait analysis either before and after surgery The following parameters were reported maximum hip and knee extension in the gait cycle to measure the gait efficiency normalized maximum power produced by the ankle during push-off phase to express the propulsive capacity normalized speed and normalized stride length as global gait performance measure
Methods Seventy-eight participants were included and a total of eighty-four SEMLS analyzed All the participants were followed by the Children Rehabilitation Unit of the Local Health Authority of Reggio Emilia Participants met the following requirements age 4-20 years hemiplegic or diplegic CP Gross Motor Function Classification System level I II or III 3D gait analysis either before and after surgery The following parameters were reported maximum hip and knee extension in the gait cycle to measure the gait efficiency normalized maximum power produced by the ankle during push-off phase to express the propulsive capacity normalized speed and normalized stride length as global gait performance measure
Detailed Description:
Children with Cerebral Palsy CP often have gait difficulties due to poor motor control spasticity skeletal deformities and muscle weakness Their walking is usually slow tiring with reduced endurance and a higher risk of falls As a result these children often have limited participation in daily activities and a lower quality of life Among the most common treatments functional orthopedic surgery is now considered the 34standard of care34 for these patients Many studies have shown that surgery has a positive impact on walking ability
In the traditional surgical approach patients undergo multiple operations each correcting a single issue For example fixing a shortened triceps muscle to allow the foot to fully contact the ground might be followed by lengthening the knee flexors to enable full knee extension and upright standing This step-by-step process where surgeries are often done annually was called the 34birthday syndrome34 Some researchers have studied the effects of surgery on specific walking issues For example in 2022 Kruger KR et al examined the long-term impact of correcting valgus-pronated feet Dohin B et al in 2020 looked at how lengthening knee flexors and adductors improved in-toeing gait Krupiński M et al in 2015 studied the effect of Achilles tendon lengthening in children with toe-walking equinus gait While these studies provided useful insights for clinicians they often oversimplified the complexity of the underlying problems
In CP multiple areas of the body are usually involved in walking difficulties as seen in crouch gait walking with bent knees which can have many causes that influence each other This often requires surgery on multiple areas at once to improve the overall balance of the body More recently surgeons have adopted a technique where multiple deformities are corrected in a single surgery often involving both lower limbs This approach known as single-event multilevel surgery SEMLS reduces the number of surgeries compared to the traditional method of addressing one issue at a time However as children grow additional SEMLS procedures may be needed to address new issues that arise such as muscle tightness Several studies have shown that these multilevel surgeries can improve walking ability Saglam Y et al in 2016 studied the combination of femoral derotational osteotomy and soft tissue procedures in children with in-toeing gait In 2022 Pierz K et al examined how SEMLS including knee flexor lengthening combined with other techniques such as triceps lengthening or tibial derotational osteotomy improved walking in children with crouch gait Moreira de Freitas Guardini K et al in 2021 also studied a large sample of children undergoing SEMLS focusing on their clinical characteristics
Evaluating the effects of surgery requires selecting appropriate outcome measures which is not always simple Most studies aim to improve 34gait quality34 but do not always confirm if the chosen parameters lead to real functional improvements for the patient Some researchers use measures from physical exams eg range of motion muscle strength or biomechanical data from gait analysis 3DGA the gold standard for assessing gait in children with CP These studies often focus on how the body moves kinematics and on spatiotemporal parameters such as walking speed and step length along with summary indices These parameters show changes in the specific area operated on and how the body moves as a whole They provide information on alignment and symmetry of the legs during movement
However a well-aligned structure does not necessarily involve that the system works efficiently meaning it minimizes energy expenditure during walking Gait efficiency is especially important in children with CP as many studies have shown that inefficient gait leads to increased energy consumption and mechanical work Therefore it is important to consider not only joint movement and overall performance but also other aspects since kinematic data and physical exams do not provide information on gait efficiency
Marconi V et al 2014 conducted a prospective study on energy consumption and mechanical work in children with CP after SEMLS Their study showed a reduction in energy consumption after surgery but the small sample size 10 children and mixed group of patients including hemiplegic diplegic and quadriplegic children limit the generalizability of the results Marconi V et al used the energy calculation method proposed by Willems PA et al 1995 while Van de Walle P et al 2012 suggested that joint power calculations might be more valid and sensitive for CP Other researchers have used indirect measures of efficiency finding correlations between energy consumption and variables like pelvic vertical oscillation assessed by the BEQ index Kerrigan DC et al 1996 or maximum knee and hip extension Noorkoiv M et al 2019 These measures have been used to assess gait efficiency in CP but not specifically to evaluate the effects of surgery
The aim of this retrospective observational study is to describe the functional characteristics of children and adolescents with spastic cerebral palsy CP undergoing SEMLS and changes in their gait efficiency following surgery
Methods
This is a retrospective monocentric observational study Outcome measures were collected before surgery T0 and after surgery T1 in a time span between 8 and 38 months The surgical recommendation was tailored to the participants39 requirements and decided through a comprehensive assessment which included a standardized physical exam radiographic studies and instrumental gait analysis
Gait analysis was performed by means of a Vicon system Oxford Metrics Group Oxford UK The system was equipped with eight optoelectronic cameras two force plates AMTI USA and two video cameras All assessments were conducted in the Motion Analysis Laboratory LAMBDA Azienda USL-IRCCS di Reggio Emilia The same assessor evaluated all participants
Age and the level of Gross Motor Function Classification System GMFCS were collected before surgery
The analyses will be conducted by the Statistics and Clinical Studies Office of the USL IRCCS in Reggio Emilia using SAS System R or SPSS software depending on availability at the time Quantitative and qualitative data will be analyzed and presented using mean standard deviation SD median interquartile range IQR and relative frequencies Central tendency measures and percentages will be accompanied by 95 confidence intervals CI Normality of quantitative data will be assessed with the Shapiro-Wilk test Appropriate statistical tests will be applied to compare measures between the two time points T0 and T1
To assess gait efficiency the mean maximum extension values will be compared between T0 and T1 in the SEMLS surgery group using the paired Student39s t-test or Wilcoxon test depending on the normality assumption Without aiming for comparison the same measurements will also be described for the non-surgical group to observe trends
For quantitative variable comparisons between the two time points the paired Student39s t-test or Wilcoxon test will be applied based on normality
In the traditional surgical approach patients undergo multiple operations each correcting a single issue For example fixing a shortened triceps muscle to allow the foot to fully contact the ground might be followed by lengthening the knee flexors to enable full knee extension and upright standing This step-by-step process where surgeries are often done annually was called the 34birthday syndrome34 Some researchers have studied the effects of surgery on specific walking issues For example in 2022 Kruger KR et al examined the long-term impact of correcting valgus-pronated feet Dohin B et al in 2020 looked at how lengthening knee flexors and adductors improved in-toeing gait Krupiński M et al in 2015 studied the effect of Achilles tendon lengthening in children with toe-walking equinus gait While these studies provided useful insights for clinicians they often oversimplified the complexity of the underlying problems
In CP multiple areas of the body are usually involved in walking difficulties as seen in crouch gait walking with bent knees which can have many causes that influence each other This often requires surgery on multiple areas at once to improve the overall balance of the body More recently surgeons have adopted a technique where multiple deformities are corrected in a single surgery often involving both lower limbs This approach known as single-event multilevel surgery SEMLS reduces the number of surgeries compared to the traditional method of addressing one issue at a time However as children grow additional SEMLS procedures may be needed to address new issues that arise such as muscle tightness Several studies have shown that these multilevel surgeries can improve walking ability Saglam Y et al in 2016 studied the combination of femoral derotational osteotomy and soft tissue procedures in children with in-toeing gait In 2022 Pierz K et al examined how SEMLS including knee flexor lengthening combined with other techniques such as triceps lengthening or tibial derotational osteotomy improved walking in children with crouch gait Moreira de Freitas Guardini K et al in 2021 also studied a large sample of children undergoing SEMLS focusing on their clinical characteristics
Evaluating the effects of surgery requires selecting appropriate outcome measures which is not always simple Most studies aim to improve 34gait quality34 but do not always confirm if the chosen parameters lead to real functional improvements for the patient Some researchers use measures from physical exams eg range of motion muscle strength or biomechanical data from gait analysis 3DGA the gold standard for assessing gait in children with CP These studies often focus on how the body moves kinematics and on spatiotemporal parameters such as walking speed and step length along with summary indices These parameters show changes in the specific area operated on and how the body moves as a whole They provide information on alignment and symmetry of the legs during movement
However a well-aligned structure does not necessarily involve that the system works efficiently meaning it minimizes energy expenditure during walking Gait efficiency is especially important in children with CP as many studies have shown that inefficient gait leads to increased energy consumption and mechanical work Therefore it is important to consider not only joint movement and overall performance but also other aspects since kinematic data and physical exams do not provide information on gait efficiency
Marconi V et al 2014 conducted a prospective study on energy consumption and mechanical work in children with CP after SEMLS Their study showed a reduction in energy consumption after surgery but the small sample size 10 children and mixed group of patients including hemiplegic diplegic and quadriplegic children limit the generalizability of the results Marconi V et al used the energy calculation method proposed by Willems PA et al 1995 while Van de Walle P et al 2012 suggested that joint power calculations might be more valid and sensitive for CP Other researchers have used indirect measures of efficiency finding correlations between energy consumption and variables like pelvic vertical oscillation assessed by the BEQ index Kerrigan DC et al 1996 or maximum knee and hip extension Noorkoiv M et al 2019 These measures have been used to assess gait efficiency in CP but not specifically to evaluate the effects of surgery
The aim of this retrospective observational study is to describe the functional characteristics of children and adolescents with spastic cerebral palsy CP undergoing SEMLS and changes in their gait efficiency following surgery
Methods
This is a retrospective monocentric observational study Outcome measures were collected before surgery T0 and after surgery T1 in a time span between 8 and 38 months The surgical recommendation was tailored to the participants39 requirements and decided through a comprehensive assessment which included a standardized physical exam radiographic studies and instrumental gait analysis
Gait analysis was performed by means of a Vicon system Oxford Metrics Group Oxford UK The system was equipped with eight optoelectronic cameras two force plates AMTI USA and two video cameras All assessments were conducted in the Motion Analysis Laboratory LAMBDA Azienda USL-IRCCS di Reggio Emilia The same assessor evaluated all participants
Age and the level of Gross Motor Function Classification System GMFCS were collected before surgery
The analyses will be conducted by the Statistics and Clinical Studies Office of the USL IRCCS in Reggio Emilia using SAS System R or SPSS software depending on availability at the time Quantitative and qualitative data will be analyzed and presented using mean standard deviation SD median interquartile range IQR and relative frequencies Central tendency measures and percentages will be accompanied by 95 confidence intervals CI Normality of quantitative data will be assessed with the Shapiro-Wilk test Appropriate statistical tests will be applied to compare measures between the two time points T0 and T1
To assess gait efficiency the mean maximum extension values will be compared between T0 and T1 in the SEMLS surgery group using the paired Student39s t-test or Wilcoxon test depending on the normality assumption Without aiming for comparison the same measurements will also be described for the non-surgical group to observe trends
For quantitative variable comparisons between the two time points the paired Student39s t-test or Wilcoxon test will be applied based on normality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None