Cerebral Palsy Clinical Trial
Official title:
Short and Longterm Evolution of Self-care and Functional Mobility After Single Event Multilevel Surgery in Children and Adolescents With Spastic Diplegic Cerebral Palsy
NCT number | NCT03059342 |
Other study ID # | S54835 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 3, 2012 |
Est. completion date | July 2020 |
Verified date | June 2023 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | July 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Years to 25 Years |
Eligibility | Inclusion Criteria: - diagnosis of diplegic CP (Rosenbaum et al., 2007); - GMFCS levels I, II, and III; - aged between 6 and 25 years; - bilateral surgery. Exclusion Criteria: - other diagnosis than cerebral palsy; - severe mental retardation (IQ < 50). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universitaire Ziekenhuizen KU Leuven |
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | change from baseline in muscle strenght with the MMT | Muscle strength was assessed with manual muscle testing (MMT) according to the Medical Research Council (MRC) using a 10-point ordinal scale (0 contraction not palpable -10 movement against gravity with maximum resistance). Muscle strength was measured in eight muscle groups: hip flexors, extensors, abductors and adductors, knee flexors and extensors, ankle dorsal and plantar flexors. A total score for muscle strength was calculated (0-80). Although the MMT is generally used in clinical practice and research, the reliability in children with CP was only tested for the upper limbs (Klingels et al., 2010). To verify the reliability of the MMT for the lower limbs, an inter-rater reliability study was performed for the purpose of this study. A standardized test procedure used in the Clinical Motion Analysis Laboratory of the University Hospital of Pellenberg was used. | after 9 weeks, 6,12,18,24,36 and 60 months | |
Secondary | quality of life with the CP Qol | Quality of life was measured with the Quality of life Questionnaire for children and teenagers with CP (CP QOl) (Waters et al., 2007). The Dutch version of the CP QOl-Child was used (Smits-Engelsman et al., 2008). It contains a parent/proxy report and a child self-report. Both for the original version of the CP QOL and the Dutch version, good reliability was established (Smits-Engelsman et al., 2008). The scale consists 66 items and contains six domains (social wellbeing and acceptance, participation and physical health, functioning, emotional wellbeing, family health and access to services). All questions are scored on a 9-point rating scale in which a score of 1 indicates very unhappy, and a score 9 very happy. For the domains of pain and impact of disability, a score of 1 indicates no pain, not concerned at all while a score of 9 refers to a lot of pain, very concerned. For each domain, total scores are calculated ranging from 0 to 100. Low scores represents a low quality of life. | before surgery, after 1,3 and 5 years |
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