Premie DCD Imaging Intervention Study

NCT04483401 | Unknown

• 1 other identifier: H16-00358
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Motor Skills Disorders; Premature Birth

Keywords

DCD; Premature Birth; Neuroimaging; Rehabilitation; Motor Skills

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• Diffusion Tensor Imaging

  Fractional anisotrophy and diffusivity (mean, axial and radial)

  12 weeks

Secondary Outcomes (5)

• Bruininks Osteretsky Test of Motor Proficiency (BOT-2)

  12 weeks

• Performance Quality Rating Scale (PQRS)

  12 weeks

• Functional connectivity

  12 weeks

• Functional magnetic resonance imaging

  12 weeks

• Morphometry (brain volume)

  12 weeks

Study Arms (2)

Waitlist

NO INTERVENTION

Waitlist 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 arm

EXPERIMENTAL

Upon 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.

Behavioral: Cognitive Orientation to Occupational Performance (CO-OP)

Interventions

Cognitive Orientation to Occupational Performance (CO-OP) BEHAVIORAL

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.

Treatment arm

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children who were born very preterm (≤ 32weeks gestational age)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Related Publications (14)

• 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.

  PMID: 22515477 BACKGROUND

• 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.

  PMID: 21900828 BACKGROUND

• 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: 20713484 BACKGROUND

• 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: 22353291 BACKGROUND

• 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: 11471396 BACKGROUND

• 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: 11345506 BACKGROUND

• 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.

  PMID: 17518922 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 14624826 BACKGROUND

• 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.

  PMID: 14624827 BACKGROUND

• 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.

  PMID: 10405499 BACKGROUND

• 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.

  PMID: 22171930 BACKGROUND

• 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.

  PMID: 18718456 BACKGROUND

• 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.

  PMID: 19730138 BACKGROUND

MeSH Terms

Conditions

Motor Skills Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jill G Zwicker, PhD, OT(C)

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill G Zwicker, PhD, OT(C)

CONTACT

604-875-2345; jill.zwicker@ubc.ca

Nur Eisma

CONTACT

604-875-2427; neisma@bcchr.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The occupational therapist assessing the filming of child performing their 3 goals at week 1 and 10 will be blinded to which week the the goals were performed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: July 23, 2020
• Study Start: May 26, 2016
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

CA (1)