Developmental Coordination Disorder in Preterm Children: Examining Brain Changes With CO-OP Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Diffusion Tensor Imaging
研究概览
简要总结
This study will leverage a current longitudinal study of brain development in preterm children. In the Miller/Grunau Trajectories study, preterm children are returning for follow-up at 8-9 years. At this appointment, children undergo MRI and neurodevelopmental testing. Children who are identified with DCD at this appointment will be invited to participate in this intervention study. Participants will have a 2nd MRI 12 weeks after the first scan. They will then receive 12 weekly sessions with an occupational therapist, followed by a third MRI.
Children with DCD who were born very preterm (<32 weeks gestational age) who are not part of the Miller/Grunau study are also eligible to participate.
详细描述
RATIONALE Developmental coordination disorder (DCD) is one of the most common disorders in children (Wann, 2007), affecting 5-6% of the school-age population; this is > 400,000 children in Canada, or 1-2 children in every classroom (American Psychiatric Association, 2013; Statistics Canada, 2013). Compared with children born at term, preterm children (born 2-4 months early) are 6-8 times more likely to develop DCD (Edwards...Zwicker, 2011). DCD significantly interferes with a child's ability to learn motor skills and to perform everyday activities, such as getting dressed, tying shoelaces, using a knife and fork, printing, playing sports, or riding a bicycle. While it was once believed that children would outgrow this condition, longitudinal research has shown that functional difficulties can persist into adolescence and adulthood (Cantell, Smyth, & Ahonen, 2003; Cousins & Smyth, 2003). Furthermore, secondary psychosocial difficulties often develop, including poor self-esteem, depression, anxiety, problems with peers, loneliness, and decreased participation in physical and social activities (Zwicker, Harris, & Klassen, 2013). Up to half of children with DCD will have co-occurring attention deficit hyperactivity disorder (ADHD) (Kadesjo & Gillberg, 1998). As a chronic health condition, DCD often interferes with an individual's function and quality of life across their lifespan (Cousins & Smyth, 2003; Zwicker et al., 2013)
The cause of DCD is not known, and it is under-recognized, under-diagnosed, and under-treated (Blank et al., 2012). In particular, the investigators do not understand the neural basis of DCD, making it difficult to understand why children with DCD struggle to learn motor skills and to determine how to best intervene to optimize function.
To change the negative trajectory of children with DCD, the investigators need a better understanding of the neural basis of DCD, along with further rehabilitation efforts to improve outcomes. Recently, the investigators and others have conducted small neuroimaging studies to begin to understand brain differences in DCD (Querne et al., 2008; Kashiwagi et al., 2009, Zwicker et al., 2010, 2011, 2012b). These studies, while novel and significant in advancing the field of DCD, are limited by small sample sizes. To further define the neural correlates of DCD, the investigators need to perform larger studies and take advantage of new neuroimaging techniques. To date, no studies have examined neural correlates of DCD in the preterm population, a group that is at particularly high risk for the disorder. In addition, brain imaging studies may determine whether improvements in motor function with current "best practice" rehabilitation intervention are associated with changes in brain structure/function. A greater understanding of the neural basis of DCD may result in earlier diagnosis and early rehabilitation to mediate better brain development.
Currently, the investigators have a study underway that assesses whether rehabilitation intervention and improved outcomes in children with DCD are associated with concurrent brain changes (H14-00397). This proposed research extends this study to determine whether preterm children with DCD show similar brain changes.
SPECIFIC OBJECTIVES AND HYPOTHESES
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The occupational therapist assessing the filming of child performing their 3 goals at week 1 and 10 will be blinded to which week the the goals were performed.
入排标准
- 年龄范围
- 8 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Our targeted sample size is
- •Inclusion Criteria:
- •children who were born very preterm (≤ 32weeks gestational age)
- •8-12 years of age
- •diagnosed with DCD (either in the community or at the Neonatal Follow-Up Program at BC Women's Hospital as part as of the Miller/Grunau Trajectories study)
- •live in the Greater Vancouver or surrounding areas
排除标准
- •children with other diagnoses that may confound the results (e.g., intellectual disability, visual impairment)
- •children who have metal anywhere in their body
研究组 & 干预措施
Waitlist
Waitlist Participants are first allocated to a waitlist condition. After the first MRI scan, participants "wait" for 12 weeks and have a second MRI scan.
Treatment arm
Upon completion on the waitlist time of 12 weeks, participants then are allocated to the treatment group. Participants are assessed by an independent occupational therapist (before and after intervention) and participate in 10 treatment sessions with a treating occupational therapist. Following the post-treatment assessment, participants have a third MRI scan.
干预措施: Cognitive Orientation to Occupational Performance (CO-OP) (Behavioral)
结局指标
主要结局
Diffusion Tensor Imaging
时间窗: 12 weeks
Fractional anisotrophy and diffusivity (mean, axial and radial)
Canadian Occupational Performance Measure (COPM)
时间窗: 12 weeks
Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals. The OT calculates an average COPM performance score and satisfaction score. These typically range between 1 and 10, and 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction. A change of 2 points indicates a clinically significant change.
次要结局
- Functional connectivity(12 weeks)
- Functional magnetic resonance imaging(12 weeks)
- Bruininks Osteretsky Test of Motor Proficiency (BOT-2)(12 weeks)
- Performance Quality Rating Scale (PQRS)(12 weeks)
- Morphometry (brain volume)(12 weeks)
研究者
Jill Zwicker
Principal Investigator
University of British Columbia
