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

NCT06624280 | Completed

• 1 other identifier: 134/2023/OSS/AUSLRE
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral palsy; Orthopedics; Gait Analysis; Child; Adolescent; Physically Challenged; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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.

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

Secondary Outcomes (8)

• Correlation between the effect of surgery and the level of impairment

  at T1( 8-38 months after SEMLS )

• Correlation between the effect of surgery and the age of participants

  at T1( 8-38 months after SEMLS )

• change from baseline in maximum hip extension

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

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

  at T1( 8-38 months after SEMLS )

• change from baseline in energy produced and absorbed

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

Study Arms (1)

SEMLS group

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.

Procedure: single-event multilevel surgery

Interventions

single-event multilevel surgery PROCEDURE

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

SEMLS group

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• D gait analysis before and after surgery

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (2)

AziendaUSL IRCCS Reggio Emilia

Reggio Emilia, 42122, Italy

Location

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (19)

• 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.

  PMID: 33620528 BACKGROUND

• 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.

  PMID: 34129771 BACKGROUND

• 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.

  PMID: 21962844 BACKGROUND

• 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.

  PMID: 17717464 BACKGROUND

• 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.

  PMID: 24268697 BACKGROUND

• 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.

  PMID: 26597935 BACKGROUND

• 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.

  PMID: 29066191 BACKGROUND

• 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.

  PMID: 34823200 BACKGROUND

• 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.

  PMID: 9183258 BACKGROUND

• 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.

  PMID: 31155663 BACKGROUND

• 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.

  PMID: 33813186 BACKGROUND

• 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.

  PMID: 35552497 BACKGROUND

• 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.

  PMID: 25107323 BACKGROUND

• 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.

  PMID: 34926149 BACKGROUND

• 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.

  PMID: 8645436 BACKGROUND

• Kadhim M, Miller F. Crouch gait changes after planovalgus foot deformity correction in ambulatory children with cerebral palsy. Gait Posture. 2014 Feb;39(2):793-8. doi: 10.1016/j.gaitpost.2013.10.020. Epub 2013 Nov 2.

  PMID: 24316233 BACKGROUND

• Almoajil H, Dawes H, Hopewell S, Toye F, Jenkinson C, Theologis T. Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: a study protocol. BMJ Open. 2020 Mar 4;10(3):e034744. doi: 10.1136/bmjopen-2019-034744.

  PMID: 32139490 BACKGROUND

• Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.

  PMID: 27188686 BACKGROUND

• Dohin B, Haddad E, Zagorda-Pallandre B, Zemour M. Outcomes of isolated soft tissue surgery for in-toeing gait in patients with ambulatory cerebral palsy. Orthop Traumatol Surg Res. 2020 Nov;106(7):1367-1371. doi: 10.1016/j.otsr.2020.06.008. Epub 2020 Sep 29.

  PMID: 33008781 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Silvia Sassi, MD

  Azienda USL IRCCS of Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 2, 2024
• Study Start: February 20, 2024
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)