Functional Follow-up After Single Event Multilevel Surgery in Children Spastic Diplegic Cerebral Palsy

NCT03059342 | Completed

• 1 other identifier: S54835
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: The aim of this study is to assess the short- and midterm evolution of self-care and functional mobility after multilevel surgery in children and adolescents with spastic diplegic cerebral palsy and to identify which factors could have an impact on these outcomes. Methods: Thirty-four participants were included. All participants will be evaluated before surgery, at 9 weeks, 6,12,18, 24, 36 and 60 months. Self-care was assessed with the Pediatric Evaluation of Disability Inventory-NL (PEDI-NL). The Mobility Questionnaire47 (MobQues47) and Functional Mobility Scale (FMS) were used to measure functional mobility. Interactions between CP, personal and environmental characteristics and evolution in time were assessed.

Conditions

Cerebral Palsy

Keywords

spastic diplegic CP; self-care; functional mobility; multilevel surgery

Outcome Measures

Primary Outcomes (3)

• change from baseline in self-care with the PEDI

  The domain of self-care was evaluated by the Pediatric Evaluation of Disability Inventory (PEDI) (Haley, 1992). In this study, the functional skills and caregiver assistance for the domain of self-care were assessed by interview of the parent. For the domain self-care the PEDI-FSS measures skill mastery on 74 items (0 unable, 1 capable) whereas the PEDI-CAS measures the amount of assistance provided during the daily performance of these functional skills on a 6-point ordinal point system (0 complete assistance, 5 independent). Scores were calculated and transformed to interval-scaled scores (0-100), where 0 represents no ability and 100 indicates full capability. The Dutch version (PEDI-NL) (Wassenberg-Severijnen \& Custers, 2005) was used. Several studies showed good reliability and excellent discriminative validity for the population of CP for the PEDI-NL (Custers et al., 2002; Wassenberg-Severijnen et al., 2003).

  after 9 weeks, 6,12,18,24,36 and 60 months

• change from baseline in functional mobility with the Functional Mobility Scale

  the Functional Mobility Scale (FMS) (Harvey, Graham, Morris, Baker, \& Wolfe, 2007) The FMS rates the mobility of children with CP on a 6-point ordinal scale based on the need for assistive devices at three specific distances: 5, 50 and 500 m. These distances represent home, school and community environments respectively. The FMS is administered by asking a few questions on the child/parent. The scale is reliable and valid and has been able to detect changes after SEMLS (Harvey et al., 2007).

  after 9 weeks, 6,12,18,24,36 and 60 months

• change from baseline in functional mobility with the Mobility Questionnaire47

  The Mobility Questionnaire (MobQues47, Van Ravesteyn, Dallmeijer, Scholtes, Roorda, \& Becher, 2009) The Dutch version of the Mobility Questionnaire (MobiliteitsVragenlijst) (Van Ravesteyn et al., 2010a) was used. This questionnaire consists of 47 items like standing and walking on bare feet, stepping on and off a bike, going in and out of a car,… experienced by the children in their own home environment (with assistive devices if normally used). The mobility limitations were rated by the parents on a 5-point ordinal questionnaire (0 not possible, 4 no problem). The total score was converted to a scale of 0 to 100. Low scores represent severe limitations of mobility. The MobQues47 was specific developed for children with CP and has good reliability and validity (Van Ravesteyn et al., 2010a; Van Ravensteyn, Scholtes, Becher, Roorda, Verschuren, \& Dallmeijer, 2010b).

  after 9 weeks, 6,12,18,24,36 and 60 months

Secondary Outcomes (2)

• change from baseline in muscle strenght with the MMT

  after 9 weeks, 6,12,18,24,36 and 60 months

• quality of life with the CP Qol

  before surgery, after 1,3 and 5 years

Interventions

single event multilevel surgery PROCEDURE

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive children and adolescents with spastic diplegic CP who underwent multilevel surgery in the University Hospital of Pellenberg were screened for entry in the study between December 2012 and August 2014. SEMLS was defined as orthopedic surgery (soft-tissue or bony surgical procedures, combined or not with botulinum toxin injection) at two or more anatomical levels during one operative procedure, requiring only one hospital admission and rehabilitation period.

You may qualify if:

• diagnosis of diplegic CP (Rosenbaum et al., 2007);
• GMFCS levels I, II, and III;
• aged between 6 and 25 years;
• bilateral surgery.

You may not qualify if:

• other diagnosis than cerebral palsy;
• severe mental retardation (IQ \< 50).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (33)

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MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Guy Molenaers, PHD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSC Occupational Science

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 23, 2017
• Study Start: December 3, 2012
• Primary Completion: December 31, 2019
• Study Completion: July 1, 2020
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share