Recruiting

DCD Imaging

Sponsor:

University of British Columbia

Code:

NCT04483401

Conditions

Motor Skills Disorders

Premature Birth

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Cognitive Orientation to Occupational Performance (CO-OP)

Study Details

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

Study ID

NCT04483401

Start date

May 26, 2016

Status verified date

Jul, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Jun 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Our targeted sample size is 15.

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Waitlist

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.

experimental: Treatment arm

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.

Interventions

Cognitive Orientation to Occupational Performance (CO-OP)

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.

Primary outcome measure

  • Canadian Occupational Performance Measure (COPM) [ Time Frame: 12 weeks ]
  • Diffusion Tensor Imaging [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Jul 23, 2020

Last verified

Jul, 2020

Keywords

  • DCD
  • Premature Birth
  • Neuroimaging
  • Rehabilitation
  • Motor Skills

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-07-23.