Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

DCD Imaging-Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02597751
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jill Zwicker, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Motor Skills Disorders Behavioral: Cognitive Orientation to Occupational Performance (CO-OP) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developmental Coordination Disorder: Integrating Brain Imaging and Rehabilitation to Improve Outcomes
Study Start Date : September 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Canadian Occupational Performance Measure [ Time Frame: 12 weeks ]
    Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals

  2. diffusion tensor imaging [ Time Frame: 12 weeks ]
    fractional anisotropy and diffusivity (mean, axial, and radial)


Secondary Outcome Measures :
  1. Bruininks Osteretsky Test of Motor Proficiency [ Time Frame: 12 weeks ]
    standardized assessment of motor skills

  2. Performance Quality Rating Scale [ Time Frame: 12 weeks ]
    qualitative observations of movement quality

  3. functional connectivity [ Time Frame: 12 weeks ]
    spatial independent components analysis of resting state networks

  4. functional magnetic resonance imaging [ Time Frame: 12 weeks ]
    patterns of brain activation during mental rotation task

  5. morphometry [ Time Frame: 12 weeks ]
    white matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597751


Contacts
Layout table for location contacts
Contact: Jill G Zwicker, PhD, OT(C) 604-875-2345 ext 5948 jill.zwicker@ubc.ca
Contact: Nur Eisma 604-875-2427 neisma@cfri.ubc.ca

Locations
Layout table for location information
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Gisela Gosse    604-875-2345 ext 5948    ggosse@cw.bc.ca   
Contact: Janet Rigney    604-875-2345 ext 5948    jrigney@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Jill G Zwicker, PhD, OT(C) University of British Columbia

Publications:

Layout table for additonal information
Responsible Party: Jill Zwicker, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02597751     History of Changes
Other Study ID Numbers: H14-00397
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Jill Zwicker, University of British Columbia:
DCD
Neuroimaging
Rehabilitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Skills Disorders
Neurodevelopmental Disorders
Mental Disorders