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DCD Imaging-Intervention Study

Primary Purpose

Motor Skills Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Orientation to Occupational Performance (CO-OP)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Skills Disorders focused on measuring DCD, Neuroimaging, Rehabilitation

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children with suspected DCD based on history and results of motor testing (MABC-2) and parent questionnaire (DCDQ) and interview
  • typically developing children who score at or above 25th percentile on MABC-2

Exclusion Criteria:

  • a medical condition that could explain motor problem, such as cerebral palsy, significant intellectual disability, or visual impairment
  • children with ferrous metal in their body

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Arm

Waitlist control

Arm Description

Participants are randomized to treatment group. After the first MRI scan, 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 second MRI scan. Twelve weeks later, participants have a third, follow-up scan.

Participants are randomized to the waitlist control group. After the first MRI scan, participants "wait" for 12 weeks and then have a 2nd MRI scan. Participants then have 10 treatment sessions with an occupational therapist and are assessed by an independent occupational therapist before and after treatment. Participants then have a third MRI scan to examine brain changes associated with intervention.

Outcomes

Primary Outcome Measures

Canadian Occupational Performance Measure
Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals
diffusion tensor imaging
fractional anisotropy and diffusivity (mean, axial, and radial)

Secondary Outcome Measures

Bruininks Osteretsky Test of Motor Proficiency
standardized assessment of motor skills
Performance Quality Rating Scale
qualitative observations of movement quality
functional connectivity
spatial independent components analysis of resting state networks
functional magnetic resonance imaging
patterns of brain activation during mental rotation task
morphometry
white matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum

Full Information

First Posted
October 19, 2015
Last Updated
July 20, 2020
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02597751
Brief Title
DCD Imaging-Intervention Study
Official Title
Developmental Coordination Disorder: Integrating Brain Imaging and Rehabilitation to Improve Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Developmental coordination disorder (DCD) affects 5-6% of the school-age population, equating to ~400,000 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 with/without 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 DCD+ADHD 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 structure/function 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 DCD+ADHD) 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 structure/function. Approach: The investigators will measure brain changes pre- and post-intervention between children with DCD and DCD+ADHD (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 child's 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 DCD+ADHD. Neuroimaging analyses will include region of interest analyses (sensory, motor, and cerebellar pathways) as well as whole brain analyses using tract-based spatial statistics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Skills Disorders
Keywords
DCD, Neuroimaging, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Participants are randomized to treatment group. After the first MRI scan, 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 second MRI scan. Twelve weeks later, participants have a third, follow-up scan.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Participants are randomized to the waitlist control group. After the first MRI scan, participants "wait" for 12 weeks and then have a 2nd MRI scan. Participants then have 10 treatment sessions with an occupational therapist and are assessed by an independent occupational therapist before and after treatment. Participants then have a third MRI scan to examine brain changes associated with intervention.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Orientation to Occupational Performance (CO-OP)
Intervention Description
CO-OP is a cognitive approach to solving functional motor problems (Polatajko et al., 2001b). Therapists teach children a global problem solving strategy (Goal-Plan-Do-Check) as a framework for developing specific strategies for overcoming motor problems; these strategies are determined after a dynamic performance analysis by the therapist to determine where the "breakdown" is in performing the task. Occupational therapists will see children once weekly for one hour over 10 weeks as per published protocol (Polatajko et al., 2001b), plus two assessment sessions. Children will select three functional motor goals to be addressed over the course of treatment, rating their performance and satisfaction of these goals pre- and post-intervention.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals
Time Frame
12 weeks
Title
diffusion tensor imaging
Description
fractional anisotropy and diffusivity (mean, axial, and radial)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Bruininks Osteretsky Test of Motor Proficiency
Description
standardized assessment of motor skills
Time Frame
12 weeks
Title
Performance Quality Rating Scale
Description
qualitative observations of movement quality
Time Frame
12 weeks
Title
functional connectivity
Description
spatial independent components analysis of resting state networks
Time Frame
12 weeks
Title
functional magnetic resonance imaging
Description
patterns of brain activation during mental rotation task
Time Frame
12 weeks
Title
morphometry
Description
white matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children with suspected DCD based on history and results of motor testing (MABC-2) and parent questionnaire (DCDQ) and interview typically developing children who score at or above 25th percentile on MABC-2 Exclusion Criteria: a medical condition that could explain motor problem, such as cerebral palsy, significant intellectual disability, or visual impairment children with ferrous metal in their body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill G Zwicker, PhD, OT(C)
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19687388
Citation
Zwicker JG, Missiuna C, Boyd LA. Neural correlates of developmental coordination disorder: a review of hypotheses. J Child Neurol. 2009 Oct;24(10):1273-81. doi: 10.1177/0883073809333537. Epub 2009 Aug 17.
Results Reference
background
PubMed Identifier
20713484
Citation
Zwicker JG, Missiuna C, Harris SR, Boyd LA. Brain activation of children with developmental coordination disorder is different than peers. Pediatrics. 2010 Sep;126(3):e678-86. doi: 10.1542/peds.2010-0059. Epub 2010 Aug 16.
Results Reference
background
PubMed Identifier
21145385
Citation
Zwicker JG, Missiuna C, Harris SR, Boyd LA. Brain activation associated with motor skill practice in children with developmental coordination disorder: an fMRI study. Int J Dev Neurosci. 2011 Apr;29(2):145-52. doi: 10.1016/j.ijdevneu.2010.12.002. Epub 2010 Dec 8.
Results Reference
background
PubMed Identifier
22353291
Citation
Zwicker JG, Missiuna C, Harris SR, Boyd LA. Developmental coordination disorder: a pilot diffusion tensor imaging study. Pediatr Neurol. 2012 Mar;46(3):162-7. doi: 10.1016/j.pediatrneurol.2011.12.007.
Results Reference
background
PubMed Identifier
24576693
Citation
Langevin LM, Macmaster FP, Crawford S, Lebel C, Dewey D. Common white matter microstructure alterations in pediatric motor and attention disorders. J Pediatr. 2014 May;164(5):1157-1164.e1. doi: 10.1016/j.jpeds.2014.01.018. Epub 2014 Feb 25.
Results Reference
background
PubMed Identifier
11345506
Citation
Polatajko HJ, Mandich AD, Missiuna C, Miller LT, Macnab JJ, Malloy-Miller T, Kinsella EA. Cognitive orientation to daily occupational performance (CO-OP): part III--the protocol in brief. Phys Occup Ther Pediatr. 2001;20(2-3):107-23.
Results Reference
background
PubMed Identifier
11471396
Citation
Miller LT, Polatajko HJ, Missiuna C, Mandich AD, Macnab JJ. A pilot trial of a cognitive treatment for children with developmental coordination disorder. Hum Mov Sci. 2001 Mar;20(1-2):183-210. doi: 10.1016/s0167-9457(01)00034-3.
Results Reference
background
PubMed Identifier
16780296
Citation
Polatajko HJ, Cantin N. Developmental coordination disorder (dyspraxia): an overview of the state of the art. Semin Pediatr Neurol. 2005 Dec;12(4):250-8. doi: 10.1016/j.spen.2005.12.007.
Results Reference
background
PubMed Identifier
23106530
Citation
Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.
Results Reference
background
PubMed Identifier
35466705
Citation
Izadi-Najafabadi S, Gunton C, Dureno Z, Zwicker JG. Effectiveness of Cognitive Orientation to Occupational Performance intervention in improving motor skills of children with developmental coordination disorder: A randomized waitlist-control trial. Clin Rehabil. 2022 Jun;36(6):776-788. doi: 10.1177/02692155221086188. Epub 2022 Apr 24.
Results Reference
derived
PubMed Identifier
34149383
Citation
Izadi-Najafabadi S, Zwicker JG. White Matter Changes With Rehabilitation in Children With Developmental Coordination Disorder: A Randomized Controlled Trial. Front Hum Neurosci. 2021 Jun 3;15:673003. doi: 10.3389/fnhum.2021.673003. eCollection 2021.
Results Reference
derived

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DCD Imaging-Intervention Study

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