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Cerebral Palsy (CP)OrthoSurg01NCT06624280

Does Orthopedic Surgery Improve Gait Efficiency in Children With Cerebral Palsy? A Retrospective Study

An observational study of Cerebral Palsy (CP), run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 20 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
single-event multilevel surgery
Type of treatment
Surgery or procedure
How many people
78 participants
Where
2 sitesItaly
Study dates
20 Feb 2024to 12 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The study population will include patients who attended the Children Rehabilitation Unit of Local Health Authority of Reggio Emilia from 2011 to 2021. The study will focus on patients diagnosed with cerebral palsy who underwent lower limb SEMLS (single-event multilevel surgery) and 3D Gait Analysis before and after surgery.

Who may be able to join

  • diagnosis of diplegic or hemiplegic CP;
  • GMFCS levels I, II, or III;
  • aged between 4 and 20 years;
  • Lower limb Single Event Multilevel Surgery (SEMLS)
  • 3D gait analysis before and after surgery

Who cannot join

  • more than one lower limb surgery event between the two gait assessments
  • one single gait evaluation

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • AziendaUSL IRCCS Reggio Emilia

    Reggio Emilia, 42122

  • Azienda Unità Sanitaria Locale Reggio Emilia

    Reggio Emilia

Other trials in Italy

About this study

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.

Read the 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 \"standard of care\" 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 \"birthday syndrome\". Some researchers have studied the effects of surgery on specific walking issues. For example, in 2022, Kruger K.R. 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 \"gait quality\" but do not always confirm if the chosen parameters lead to real functional improvements for the patient. Some researchers use measures from physical exams (e.g., 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 P.A. 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 D.C. 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 participants\' 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 Student\'s 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 Student\'s t-test or Wilcoxon test will be applied based on normality.

Being tested
single-event multilevel surgery
Keywords
Cerebral palsy, Orthopedics, Gait Analysis, Child, Adolescent, Physically Challenged, Rehabilitation
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single-event multilevel surgeryProcedure or surgery

    surgical orthopedic approach where multiple deformities are corrected in one solution, often involving both lower limbs, to improve walking performance

Study groups in NCT06624280
Study groupRoleWhat they receive
SEMLS groupThe study population will include patients who attended the Children Rehabilitation Unit of Local Health Authority of Reggio Emilia from 2011 to 2021. The study will focus on patients diagnosed with cerebral palsy who underwent lower limb SEMLS (single-event multilevel surgery) and 3D Gait Analysis before and after surgery.
Receives: Procedure: single-event multilevel surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean maximum knee extension in the gait cycle

    It is an indirect measure of walking efficiency. Greater knee extension leads to lower energy consumption.

    The measurement is calculated using 3D Gait Analysis. It has already been used to assess gait efficiency in children with CP (Noorkoiv, 2019), but never to evaluate the effects of surgery. These measures are useful when dynamic data are not available, such as when the stride length is short or the patient has low endurance, making it difficult to collect such data

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

  2. change from baseline in maximum knee extension

    It is an indirect measure of walking efficiency. Greater knee extension leads to lower energy consumption.

    The measurement is calculated using 3D Gait Analysis. It has already been used to assess gait efficiency in children with CP (Noorkoiv, 2019), but never to evaluate the effects of surgery. These measures are useful when dynamic data are not available, such as when the stride length is short or the patient has low endurance, making it difficult to collect such data.

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

Secondary outcomes (8)
  1. Correlation between the effect of surgery and the level of impairment

    Pearson's correlation will assess the relationship between age and surgical effect, measured as the difference in maximum knee extension. Additional correlation measures will be calculated to evaluate the relationship between surgical effect and the degree of impairment in patients.

    Measured: at T1( 8-38 months after SEMLS )

  2. Correlation between the effect of surgery and the age of participants

    Pearson's correlation will assess the relationship between age and surgical effect, measured as the difference in maximum knee extension. Additional correlation measures will be calculated to evaluate the relationship between surgical effect and the degree of impairment in patients

    Measured: at T1( 8-38 months after SEMLS )

  3. change from baseline in maximum hip extension

    It is an indirect measure of walking efficiency. Greater knee extension leads to lower energy consumption.

    The measurement is calculated using 3D Gait Analysis. It has already been used to assess gait efficiency in children with CP (Noorkoiv, 2019), but never to evaluate the effects of surgery. These measures are useful when dynamic data are not available, such as when the stride length is short or the patient has low endurance, making it difficult to collect such data.

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

  4. change from baseline in power produced by the ankle during push-off phase

    This parameter was chosen to assess efficiency because research shows that having adequate push-off strength is important for efficient walking (Jonkers et al., 2009). Keeping good propulsion ability after surgery is therefore a priority. Some authors have noted the risk of over-correction (Dietz et al., 2006; Sclavor et al., 2022), which can lead to iatrogenic weakness in the triceps and reduced walking efficiency (J. Lorentzen et al., 2020).

    Measured: at T1( 8-38 months after SEMLS )

  5. change from baseline in energy produced and absorbed

    This parameter was chosen to assess efficiency because research shows that having adequate push-off strength is important for efficient walking (Jonkers et al., 2009). Keeping good propulsion ability after surgery is therefore a priority. Some authors have noted the risk of over-correction (Dietz et al., 2006; Sclavor et al., 2022), which can lead to iatrogenic weakness in the triceps and reduced walking efficiency (J. Lorentzen et al., 2020).

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

  6. Change from baseline in Biomechanical Efficiency Quotient (BEQ)

    To evaluate walking efficiency, the Biomechanical Efficiency Quotient (BEQ) (Kerrigan et al., 1996) was also included, obtained from three parameters: average step length, vertical displacement of the trunk during walking and height of the sacrum during standing. Kerrigan et al., show that this summary index is useful for evaluating the impact of physical therapy interventions, such as the use of Ankle Foot Orthosis (AFO), on biomechanical efficiency. From reviewing the literature, it appears that this measure has never been used to assess the effect of surgery.

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

  7. Change from baseline in Gait Profile Score (GPS)

    As a measure to evaluate gait quality, the Gait Profile Score (GPS) (Baker et al., 2009) was chosen. It is a general index that summarizes the overall deviation of kinematic gait data from reference data (Moreira de Freitas Guardini K. et al., 2021). The GPS can be broken down into the Gait Variable Score (GVS), which is based on nine kinematic variables: pelvic tilt, pelvic rotation, pelvic obliquity, hip and knee flexion/extension, ankle dorsiflexion/plantarflexion, hip abduction/adduction, hip rotation, and foot progression angle (Speciali DS et al., 2014).

    A decrease in the GPS score is considered an improvement. In the 2012 study, Baker et al. also defined the Minimal Clinical Important Difference (MCID), which is the smallest clinically relevant difference for this parameter. For the GPS, the MCID is 1.6°

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

  8. Change from baseline in speed, Stride length, ratio frequency/stride lenght, stance time and double support

    The spatiotemporal kinematic parameters will be used to compare overall walking performance, as done by other authors like Pierz et al. in 2022.

    Measured: T0 (before SEML) and T1 (8-38 months after SEMLS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start20 Feb 2024
  3. Primary completion12 Sep 2024
  4. Study completion12 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06624280
Sponsor's protocol ID
134/2023/OSS/AUSLRE
Acronym
OrthoSurg01
Status last verified
Oct 2024
First submitted
20 Sep 2024
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect participant privacy the IPD will not be shared, unless upon reasonable request.

Publications

  • Visscher R, Hasler N, Freslier M, Singh NB, Taylor WR, Brunner R, Rutz E. Long-term follow-up after multilevel surgery in cerebral palsy. Arch Orthop Trauma Surg. 2022 Sep;142(9):2131-2138. doi: 10.1007/s00402-021-03797-0. Epub 2021 Feb 23.

    PubMed 33620528
  • Vermuyten L, Desloovere K, Molenaers G, Van Campenhout A. Proximal femoral derotation osteotomy in children with CP : long term outcome and the role of age at time of surgery. Acta Orthop Belg. 2021 Mar;87(1):167-173.

    PubMed 34129771
  • Van de Walle P, Hallemans A, Schwartz M, Truijen S, Gosselink R, Desloovere K. Mechanical energy estimation during walking: validity and sensitivity in typical gait and in children with cerebral palsy. Gait Posture. 2012 Feb;35(2):231-7. doi: 10.1016/j.gaitpost.2011.09.012. Epub 2011 Oct 2.

    PubMed 21962844
  • van den Hecke A, Malghem C, Renders A, Detrembleur C, Palumbo S, Lejeune TM. Mechanical work, energetic cost, and gait efficiency in children with cerebral palsy. J Pediatr Orthop. 2007 Sep;27(6):643-7. doi: 10.1097/BPO.0b013e318093f4c3.

    PubMed 17717464
  • Schwartz MH, Rozumalski A, Novacheck TF. Femoral derotational osteotomy: surgical indications and outcomes in children with cerebral palsy. Gait Posture. 2014 Feb;39(2):778-83. doi: 10.1016/j.gaitpost.2013.10.016. Epub 2013 Oct 27.

    PubMed 24268697
  • Saglam Y, Ekin Akalan N, Temelli Y, Kuchimov S. Femoral derotation osteotomy with multi-level soft tissue procedures in children with cerebral palsy: Does it improve gait quality? J Child Orthop. 2016 Feb;10(1):41-8. doi: 10.1007/s11832-015-0706-4. Epub 2015 Nov 23.

    PubMed 26597935
  • Ries AJ, Schwartz MH. Low gait efficiency is the primary reason for the increased metabolic demand during gait in children with cerebral palsy. Hum Mov Sci. 2018 Feb;57:426-433. doi: 10.1016/j.humov.2017.10.004. Epub 2017 Oct 21.

    PubMed 29066191
  • Pierz K, Brimacombe M, Ounpuu S. Percutaneous hamstring lengthening in cerebral palsy: Technique and gait outcomes based on GMFCS level. Gait Posture. 2022 Jan;91:318-325. doi: 10.1016/j.gaitpost.2021.10.035. Epub 2021 Oct 29.

    PubMed 34823200
  • Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

    PubMed 9183258
  • Noorkoiv M, Lavelle G, Theis N, Korff T, Kilbride C, Baltzopoulos V, Shortland A, Levin W, Ryan JM. Predictors of Walking Efficiency in Children With Cerebral Palsy: Lower-Body Joint Angles, Moments, and Power. Phys Ther. 2019 Jun 1;99(6):711-720. doi: 10.1093/ptj/pzz041.

    PubMed 31155663
  • de Freitas Guardini KM, Kawamura CM, Lopes JAF, Fujino MH, Blumetti FC, de Morais Filho MC. Factors related to better outcomes after single-event multilevel surgery (SEMLS) in patients with cerebral palsy. Gait Posture. 2021 May;86:260-265. doi: 10.1016/j.gaitpost.2021.03.032. Epub 2021 Mar 27.

    PubMed 33813186
  • Moisan G, Bonnefoy-Mazure A, De Coulon G, Tabard-Fougere A, Armand S, Turcot K. Assessment of gait quality and efficiency after undergoing a single-event multilevel surgery in children with cerebral palsy presenting an intoeing gait pattern. Childs Nerv Syst. 2022 Aug;38(8):1523-1530. doi: 10.1007/s00381-022-05548-x. Epub 2022 May 12.

    PubMed 35552497
  • Marconi V, Hachez H, Renders A, Docquier PL, Detrembleur C. Mechanical work and energy consumption in children with cerebral palsy after single-event multilevel surgery. Gait Posture. 2014 Sep;40(4):633-9. doi: 10.1016/j.gaitpost.2014.07.014. Epub 2014 Jul 24.

    PubMed 25107323
  • Kruger KM, Constantino CS, Graf A, Flanagan A, Smith PA, Krzak JJ. What are the long-term outcomes of lateral column lengthening for pes planovalgus in cerebral palsy? J Clin Orthop Trauma. 2021 Nov 26;24:101717. doi: 10.1016/j.jcot.2021.101717. eCollection 2022 Jan.

    PubMed 34926149
  • Kerrigan DC, Thirunarayan MA, Sheffler LR, Ribaudo TA, Corcoran PJ. A tool to assess biomechanical gait efficiency; a preliminary clinical study. Am J Phys Med Rehabil. 1996 Jan-Feb;75(1):3-8. doi: 10.1097/00002060-199601000-00003.

    PubMed 8645436

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy (CP), run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean maximum knee extension in the gait cycle (time frame: T0 (before SEML) and T1 (8-38 months after SEMLS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06624280, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.

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