NCT02597751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

5.4 years

First QC Date

October 19, 2015

Last Update Submit

July 20, 2020

Conditions

Motor Skills Disorders

Keywords

DCDNeuroimagingRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals

    12 weeks

  • diffusion tensor imaging

    fractional anisotropy and diffusivity (mean, axial, and radial)

    12 weeks

Secondary Outcomes (5)

  • Bruininks Osteretsky Test of Motor Proficiency

    12 weeks

  • Performance Quality Rating Scale

    12 weeks

  • functional connectivity

    12 weeks

  • functional magnetic resonance imaging

    12 weeks

  • morphometry

    12 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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)

Waitlist control

NO INTERVENTION

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.

Interventions

Cognitive Orientation to Occupational Performance (CO-OP)BEHAVIORAL

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.

Treatment Arm

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (13)

  • 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.

    PMID: 19687388BACKGROUND

  • 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.

    PMID: 20713484BACKGROUND

  • 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.

    PMID: 21145385BACKGROUND

  • 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.

    PMID: 22353291BACKGROUND

  • 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.

    PMID: 24576693BACKGROUND

  • 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.

    PMID: 11345506BACKGROUND

  • 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.

    PMID: 11471396BACKGROUND

  • 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.

    PMID: 16780296BACKGROUND

  • 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.

    PMID: 23106530BACKGROUND

  • Malik MA, Weber AM, Lang D, Vanderwal T, Zwicker JG. Changes in cortical grey matter volume with Cognitive Orientation to daily Occupational Performance intervention in children with developmental coordination disorder. Front Hum Neurosci. 2024 May 22;18:1316117. doi: 10.3389/fnhum.2024.1316117. eCollection 2024.

    PMID: 38841123DERIVED

  • Malik M, Weber A, Lang D, Vanderwal T, Zwicker JG. Cortical grey matter volume differences in children with developmental coordination disorder compared to typically developing children. Front Hum Neurosci. 2024 May 17;18:1276057. doi: 10.3389/fnhum.2024.1276057. eCollection 2024.

    PMID: 38826616DERIVED

  • 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.

    PMID: 35466705DERIVED

  • 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.

    PMID: 34149383DERIVED

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Jill G Zwicker, PhD, OT(C)

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 19, 2015

First Posted

November 5, 2015

Study Start

September 1, 2014

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

CA(1)