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Motor Skills DisordersNCT04483401

Premie DCD Imaging Intervention Study

A study testing Cognitive Orientation to Occupational Performance (CO-OP) in people with Motor Skills Disorders and Premature Birth, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will leverage a current longitudinal study of brain development in preterm children. In the Miller/Grunau Trajectories study, preterm children are returning for follow-up at 8-9 years. At this appointment, children undergo MRI and neurodevelopmental testing. Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Motor Skills Disorders, Premature Birth
What is being tested?
Cognitive Orientation to Occupational Performance (CO-OP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
26 May 2016to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children who were born very preterm (≤ 32weeks gestational age)
  • 8-12 years of age
  • diagnosed with DCD (either in the community or at the Neonatal Follow-Up Program at BC Women's Hospital as part as of the Miller/Grunau Trajectories study)
  • live in the Greater Vancouver or surrounding areas

Who cannot join

  • children with other diagnoses that may confound the results (e.g., intellectual disability, visual impairment)
  • children who have metal anywhere in their body

Trial locations and contacts

1 site in 1 country.

Jill G Zwicker, PhD, OT(C) contact

604-875-2345 ext. 5948

jill.zwicker@ubc.ca

Canada1 site, 1 recruiting
  • University of British Columbia

    Vancouver, British Columbia, V6H 3V4

    Gisela Gosse, BScN, 604-875-2345 ext. 5948, ggosse@cw.bc.ca

    Janet Rigney, 604-875-2345 ext. 5948, jrigney@cw.bc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Developmental Coordination Disorder in Preterm Children: Examining Brain Changes With CO-OP Intervention

This study will leverage a current longitudinal study of brain development in preterm children. In the Miller/Grunau Trajectories study, preterm children are returning for follow-up at 8-9 years. At this appointment, children undergo MRI and neurodevelopmental testing. Children who are identified with DCD at this appointment will be invited to participate in this intervention study. Participants will have a 2nd MRI 12 weeks after the first scan. They will then receive 12 weekly sessions with an occupational therapist, followed by a third MRI.

Children with DCD who were born very preterm (<32 weeks gestational age) who are not part of the Miller/Grunau study are also eligible to participate.

Read the detailed description

RATIONALE Developmental coordination disorder (DCD) is one of the most common disorders in children (Wann, 2007), affecting 5-6% of the school-age population; this is > 400,000 children in Canada, or 1-2 children in every classroom (American Psychiatric Association, 2013; Statistics Canada, 2013). Compared with children born at term, preterm children (born 2-4 months early) are 6-8 times more likely to develop DCD (Edwards…Zwicker, 2011). DCD significantly interferes with a child's ability to learn motor skills and to perform everyday activities, such as getting dressed, tying shoelaces, using a knife and fork, printing, playing sports, or riding a bicycle. While it was once believed that children would outgrow this condition, longitudinal research has shown that functional difficulties can persist into adolescence and adulthood (Cantell, Smyth, \& Ahonen, 2003; Cousins \& Smyth, 2003). Furthermore, secondary psychosocial difficulties often develop, including poor self-esteem, depression, anxiety, problems with peers, loneliness, and decreased participation in physical and social activities (Zwicker, Harris, \& Klassen, 2013). Up to half of children with DCD will have co-occurring attention deficit hyperactivity disorder (ADHD) (Kadesjo \& Gillberg, 1998). As a chronic health condition, DCD often interferes with an individual's function and quality of life across their lifespan (Cousins \& Smyth, 2003; Zwicker et al., 2013)

The cause of DCD is not known, and it is under-recognized, under-diagnosed, and under-treated (Blank et al., 2012). In particular, the investigators do not understand the neural basis of DCD, making it difficult to understand why children with DCD struggle to learn motor skills and to determine how to best intervene to optimize function.

To change the negative trajectory of children with DCD, the investigators need a better understanding of the neural basis of DCD, along with further rehabilitation efforts to improve outcomes. Recently, the investigators and others have conducted small neuroimaging studies to begin to understand brain differences in DCD (Querne et al., 2008; Kashiwagi et al., 2009, Zwicker et al., 2010, 2011, 2012b). These studies, while novel and significant in advancing the field of DCD, are limited by small sample sizes. To further define the neural correlates of DCD, the investigators need to perform larger studies and take advantage of new neuroimaging techniques. To date, no studies have examined neural correlates of DCD in the preterm population, a group that is at particularly high risk for the disorder. In addition, brain imaging studies may determine whether improvements in motor function with current "best practice" rehabilitation intervention are associated with changes in brain structure/function. A greater understanding of the neural basis of DCD may result in earlier diagnosis and early rehabilitation to mediate better brain development.

Currently, the investigators have a study underway that assesses whether rehabilitation intervention and improved outcomes in children with DCD are associated with concurrent brain changes (H14-00397). This proposed research extends this study to determine whether preterm children with DCD show similar brain changes.

SPECIFIC OBJECTIVES AND HYPOTHESES

The proposed study (in conjunction with my current DCD-imaging-intervention study: H14-00397) will allow us to compare brain structure and function in full-term children with DCD and in preterm children with the disorder. While the investigators expect similar neural correlates between the two groups, the investigators hypothesize that the preterm DCD may also show unique brain differences, which may affect their response to rehabilitation. The investigators will address two specific objectives as outlined below:

Objective 1: To characterize structural and functional brain differences in full-term and preterm children with DCD.

Hypothesis: In our current study, the investigators hypothesized that, compared to typically-developing children, children with full-term DCD will show smaller cerebellar volume, differences in microstructural development in motor, sensory and cerebellar pathways, and decreased strength of connectivity in resting, default mode, and motor networks. The investigators expect that preterm children will show similar structural and functional brain differences as full-term children with DCD, but that they may also show mild white matter injury.

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, and functional connectivity MRI to measure connectivity in different brain networks. The investigators will also explore fMRI during a mental rotation task and spectroscopy of the basal ganglia.

Objective 2: To determine if current best-practice rehabilitation intervention induces neuroplastic changes in brain structure/function and positive outcomes in preterm children with DCD.

Hypotheses: Compared to their waitlist scan, the investigators expect that post-treatment scans of preterm children 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 at three time points: once before a waiting period as a baseline scan (conducted as part of the Miller-Grunau Trajectories study at age 8-9 years: C05-0579), once immediately before beginning treatment (12 weeks after the first scan), and once after 12 weeks of intervention. 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 investigators 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).

Being tested
Cognitive Orientation to Occupational Performance (CO-OP)
Keywords
DCD, Premature Birth, Neuroimaging, Rehabilitation, Motor Skills
Medical subject headings
Motor Skills Disorders, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Orientation to Occupational Performance (CO-OP)Behavioural

    Intervention: 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. CO-OP intervention will be administered by occupational therapists who have been trained in the CO-OP approach. Children will be seen once weekly for one hour over 12 weeks at as per published protocol (Polatajko et al., 2001b). Parents or caregivers will be encouraged to attend treatment sessions so that therapists can instruct them how to facilitate strategy use between treatment 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.

Study groups in NCT04483401
Study groupRoleWhat they receive
WaitlistNo interventionWaitlist Participants are first allocated to a waitlist condition. After the first MRI scan, participants "wait" for 12 weeks and have a second MRI scan.
Treatment armExperimentalUpon completion on the waitlist time of 12 weeks, participants then are allocated to the treatment group. 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 third MRI scan.
Receives: Behavioral: Cognitive Orientation to Occupational Performance (CO-OP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Canadian Occupational Performance Measure (COPM)

    Children will rate performance and satisfaction (10 point Likert scale) of their three motor goals. The OT calculates an average COPM performance score and satisfaction score. These typically range between 1 and 10, and 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction. A change of 2 points indicates a clinically significant change.

    Measured: 12 weeks

  2. Diffusion Tensor Imaging

    Fractional anisotrophy and diffusivity (mean, axial and radial)

    Measured: 12 weeks

Secondary outcomes (5)
  1. Bruininks Osteretsky Test of Motor Proficiency (BOT-2)

    Standardized assessment of motor skills. The investigators will measures fine and gross motor skills using the short form of the BOT-2 which assesses 14 items divided between fine manual control, manual coordination, body coordination, and strength/agility. The results are both Standard Score and Percentile Rank. The higher percentile means better motor skills.

    Measured: 12 weeks

  2. Performance Quality Rating Scale (PQRS)

    Qualitative observations of movement quality. An independent occupational therapist blinded to the intervention will score the motor performance using the Performance Quality Rating Scale (PQRS) which is composed of Part A, a 10-point performance rating scale to rate actual performance, and Part B, an 11-point magnitude of change scale to rate differences in performance between pre- and post-intervention (down to -5 for worse performance, 0 for no change, and up to +5 for improved performance). A higher change score indicates more improvement. An increase of 3 points is considered clinically significant.

    Measured: 12 weeks

  3. Functional connectivity

    Spatial independent components analysis of resting state networks

    Measured: 12 weeks

  4. Functional magnetic resonance imaging

    Patterns of brain activation during mental rotation task

    Measured: 12 weeks

  5. Morphometry (brain volume)

    White matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start26 May 2016
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
Participants are either recruited from the Trajectories Study at their 8-year follow-up visit where the Neonatal Follow-Up Team has determined that the child has DCD and meets inclusion criteria for the study, or participants may contact the research coordinator after seeing a recruitment flyer for this study. Both groups will receive occupational therapy once weekly for 10 weeks using the published protocol for the CO-OP approach.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483401
Sponsor's protocol ID
H16-00358
Status last verified
Jul 2020
First submitted
7 Nov 2019
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zwicker JG, Harris SR, Klassen AF. Quality of life domains affected in children with developmental coordination disorder: a systematic review. Child Care Health Dev. 2013 Jul;39(4):562-80. doi: 10.1111/j.1365-2214.2012.01379.x. Epub 2012 Apr 20.

    PubMed 22515477
  • Edwards J, Berube M, Erlandson K, Haug S, Johnstone H, Meagher M, Sarkodee-Adoo S, Zwicker JG. Developmental coordination disorder in school-aged children born very preterm and/or at very low birth weight: a systematic review. J Dev Behav Pediatr. 2011 Nov;32(9):678-87. doi: 10.1097/DBP.0b013e31822a396a.

    PubMed 21900828
  • 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.

    PubMed 20713484
  • 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.

    PubMed 22353291
  • 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.

    PubMed 11471396
  • 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.

    PubMed 11345506
  • Wann J. Current approaches to intervention in children with developmental coordination disorder. Dev Med Child Neurol. 2007 Jun;49(6):405. doi: 10.1111/j.1469-8749.2007.00405.x. No abstract available.

    PubMed 17518922
  • Statistics Canada. Population by sex and age group. http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo10a-eng.htm. Published 2014. Accessed January 5, 2015.

  • Cantell MH, Smyth MM, Ahonen TP. Two distinct pathways for developmental coordination disorder: persistence and resolution. Hum Mov Sci. 2003 Nov;22(4-5):413-31. doi: 10.1016/j.humov.2003.09.002.

    PubMed 14624826
  • Cousins M, Smyth MM. Developmental coordination impairments in adulthood. Hum Mov Sci. 2003 Nov;22(4-5):433-59. doi: 10.1016/j.humov.2003.09.003.

    PubMed 14624827
  • Kadesjo B, Gillberg C. Developmental coordination disorder in Swedish 7-year-old children. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):820-8. doi: 10.1097/00004583-199907000-00011.

    PubMed 10405499
  • Blank R, Smits-Engelsman B, Polatajko H, Wilson P; European Academy for Childhood Disability. European Academy for Childhood Disability (EACD): recommendations on the definition, diagnosis and intervention of developmental coordination disorder (long version). Dev Med Child Neurol. 2012 Jan;54(1):54-93. doi: 10.1111/j.1469-8749.2011.04171.x. No abstract available.

    PubMed 22171930
  • Querne L, Berquin P, Vernier-Hauvette MP, Fall S, Deltour L, Meyer ME, de Marco G. Dysfunction of the attentional brain network in children with Developmental Coordination Disorder: a fMRI study. Brain Res. 2008 Dec 9;1244:89-102. doi: 10.1016/j.brainres.2008.07.066. Epub 2008 Jul 29.

    PubMed 18718456
  • Kashiwagi M, Iwaki S, Narumi Y, Tamai H, Suzuki S. Parietal dysfunction in developmental coordination disorder: a functional MRI study. Neuroreport. 2009 Oct 7;20(15):1319-24. doi: 10.1097/WNR.0b013e32832f4d87.

    PubMed 19730138

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Orientation to Occupational Performance (CO-OP) in people with Motor Skills Disorders and Premature Birth, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jill G Zwicker, PhD, OT(C) (604-875-2345 ext. 5948, jill.zwicker@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (COPM) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483401, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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