Ignite Creation Date:
2024-05-06 @ 7:44 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02597751
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2015-10-19
Brief Title:
DCD Imaging-Intervention Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Developmental Coordination Disorder Integrating Brain Imaging and Rehabilitation to Improve Outcomes
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Developmental coordination disorder DCD affects 5-6 of the school-age population equating to 400000 children or 1-2 students in every Canadian classroom Children with DCD find it hard to learn motor skills and perform everyday activities such as getting dressed tying shoelaces using utensils printing riding a bicycle or playing sports Researchers and clinicians do not know what causes DCD or why children with DCD struggle to learn motor skills Using MRI this study will increase understanding of how the brain differs in children withwithout DCD and determine if rehabilitation can change the brain and improve outcomes of children with the disorder
Detailed Description:
SPECIFIC OBJECTIVES AND HYPOTHESES
The proposed study proposed is designed to test the overall hypothesis that compared to typically-developing children children with DCD - ADHD will show differences in brain structure and function and that rehabilitation will be associated with brain differences that reflect improvement of motor function The investigators will address three specific objectives
Objective 1 To characterize structural and functional brain differences in children with DCD and typically-developing children
Hypothesis Compared to typically-developing children the investigators expect that children with DCD will show smaller cerebellar volume differences in microstructural development in motor sensory and cerebellar pathways decreased strength of connectivity in resting default mode and motor networks Children with DCDADHD will show poorer function in frontal and parietal areas compared to children with DCD Langevin et al 2014
Approach The investigators will use magnetic resonance MR imaging and advanced MR techniques to characterize brain structure and function the investigators will use morphometry to measure cerebral and cerebellar volumes diffusion tensor imaging DTI to assess microstructural development functional connectivity MRI to measure connectivity in different brain networks and fMRI to explore patterns of brain activation during a mental rotation task
Objective 2 To determine if current best-practice rehabilitation intervention induces neuroplastic changes in brain structurefunction and positive outcomes in children with DCD
Hypotheses Compared to children in the waitlist control group the investigators expect that children in two treatment groups DCD and DCDADHD will show 1 strengthened functional connectivity in resting default mode and motor networks 2 increased integrity of the frontal-cerebellar pathway 3 increased gray matter volume in the dorsolateral prefrontal motor and cerebellar cortices and 4 improved performance and satisfaction ratings of child-chosen functional motor goals The investigators also expect that there will be a positive association between functional improvements and changes in brain structurefunction
Approach The investigators will measure brain changes pre- and post-intervention between children with DCD and DCDADHD treatment versus waitlist control As part of treatment children will identify three functional motor goals as a target for intervention The investigators will use the Canadian Occupational Performance Measure COPM Law et al 2005 to measure the childs rating of their performance and satisfaction pre- and post-intervention To supplement the COPM the occupational therapist will videotape the child performing each of their motor goals before and after intervention and an independent occupational therapist will use the Performance Quality Rating Scale PQRS to objectively measure performance and change in performance Miller et al 2001 As a secondary measure the investigators will evaluate fine and gross motor skills using the Bruininks-Oseretsky Test of Motor Proficiency-2 BOT-2 Bruininks Bruininks 2005
Objective 3 To determine if neuroplastic and functional changes are retained at 3-month follow-up
Hypothesis The investigators expect children who maintained functional gains will show increased functional connectivity in brain networks increased integrity of the frontal-cerebellar pathway and increased gray matter volume as in Objective 2 compared to children who did not maintain their functional gains If most of the children maintain their functional gains the investigators expect improvements in brain structure and function to have remained or improved from the post-intervention scan
Approach MR sequences and child ratings of performance and satisfaction of their functional motor goals will be repeated in both treatment and waitlist groups
The investigators intend to recruit 30 typically-developing children 30 children with DCD and 30 children with DCDADHD
Neuroimaging analyses will include region of interest analyses sensory motor and cerebellar pathways as well as whole brain analyses using tract-based spatial statistics
The proposed study proposed is designed to test the overall hypothesis that compared to typically-developing children children with DCD - ADHD will show differences in brain structure and function and that rehabilitation will be associated with brain differences that reflect improvement of motor function The investigators will address three specific objectives
Objective 1 To characterize structural and functional brain differences in children with DCD and typically-developing children
Hypothesis Compared to typically-developing children the investigators expect that children with DCD will show smaller cerebellar volume differences in microstructural development in motor sensory and cerebellar pathways decreased strength of connectivity in resting default mode and motor networks Children with DCDADHD will show poorer function in frontal and parietal areas compared to children with DCD Langevin et al 2014
Approach The investigators will use magnetic resonance MR imaging and advanced MR techniques to characterize brain structure and function the investigators will use morphometry to measure cerebral and cerebellar volumes diffusion tensor imaging DTI to assess microstructural development functional connectivity MRI to measure connectivity in different brain networks and fMRI to explore patterns of brain activation during a mental rotation task
Objective 2 To determine if current best-practice rehabilitation intervention induces neuroplastic changes in brain structurefunction and positive outcomes in children with DCD
Hypotheses Compared to children in the waitlist control group the investigators expect that children in two treatment groups DCD and DCDADHD will show 1 strengthened functional connectivity in resting default mode and motor networks 2 increased integrity of the frontal-cerebellar pathway 3 increased gray matter volume in the dorsolateral prefrontal motor and cerebellar cortices and 4 improved performance and satisfaction ratings of child-chosen functional motor goals The investigators also expect that there will be a positive association between functional improvements and changes in brain structurefunction
Approach The investigators will measure brain changes pre- and post-intervention between children with DCD and DCDADHD treatment versus waitlist control As part of treatment children will identify three functional motor goals as a target for intervention The investigators will use the Canadian Occupational Performance Measure COPM Law et al 2005 to measure the childs rating of their performance and satisfaction pre- and post-intervention To supplement the COPM the occupational therapist will videotape the child performing each of their motor goals before and after intervention and an independent occupational therapist will use the Performance Quality Rating Scale PQRS to objectively measure performance and change in performance Miller et al 2001 As a secondary measure the investigators will evaluate fine and gross motor skills using the Bruininks-Oseretsky Test of Motor Proficiency-2 BOT-2 Bruininks Bruininks 2005
Objective 3 To determine if neuroplastic and functional changes are retained at 3-month follow-up
Hypothesis The investigators expect children who maintained functional gains will show increased functional connectivity in brain networks increased integrity of the frontal-cerebellar pathway and increased gray matter volume as in Objective 2 compared to children who did not maintain their functional gains If most of the children maintain their functional gains the investigators expect improvements in brain structure and function to have remained or improved from the post-intervention scan
Approach MR sequences and child ratings of performance and satisfaction of their functional motor goals will be repeated in both treatment and waitlist groups
The investigators intend to recruit 30 typically-developing children 30 children with DCD and 30 children with DCDADHD
Neuroimaging analyses will include region of interest analyses sensory motor and cerebellar pathways as well as whole brain analyses using tract-based spatial statistics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None