DCD Imaging-Intervention Study

July 20, 2020 updated by: Jill Zwicker, University of British Columbia

Developmental Coordination Disorder: Integrating Brain Imaging and Rehabilitation to Improve Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
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.
Behavioral: Cognitive Orientation to Occupational Performance (CO-OP)
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.
No Intervention: Waitlist control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: 12 weeks
Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals
12 weeks
diffusion tensor imaging
Time Frame: 12 weeks
fractional anisotropy and diffusivity (mean, axial, and radial)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bruininks Osteretsky Test of Motor Proficiency
Time Frame: 12 weeks
standardized assessment of motor skills
12 weeks
Performance Quality Rating Scale
Time Frame: 12 weeks
qualitative observations of movement quality
12 weeks
functional connectivity
Time Frame: 12 weeks
spatial independent components analysis of resting state networks
12 weeks
functional magnetic resonance imaging
Time Frame: 12 weeks
patterns of brain activation during mental rotation task
12 weeks
morphometry
Time Frame: 12 weeks
white matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-00397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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