Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rhythmic Motor Learning in Children With Developmental Coordination Disorders (EPIC2)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03150784
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
University of Oxford
National University of Ireland, Maynooth
Information provided by (Responsible Party):
Helen Dawes, Oxford Brookes University

Brief Summary:

The importance of play and physical activity include many benefits on positively improving health and well-being, enhancing children's and young people's thinking and performance in school, improving their sleep and enabling confidence and skill building. However, some children find it hard to learn and perform motor skills, and are at risk of decreased participation in sports and physical activity and subsequently decreased physical fitness and overall health and well-being.

Previous studies from the research group have explored the impact and recovery following acute exercise at different intensities in children and adolescents with and without movement difficulties. Following this, a pathway promoting physical activity and engagement has been successfully established within schools for those with and without movement difficulties. Taking the previous studies further, we want to specifically focus on the children's performance and learning of a sporting skill, such as stepping, and the associated brain activity changes, using available high resolution imaging techniques. This will help us understand how these children perform and learn motor and sporting skills. Evidence obtained from imaging alongside measures of movement has helped the development of optimal therapeutic approaches for other conditions such as stroke and Parkinson's and will help us to develop approaches to help children best learn motor skills and hence gain confidence in performing sporting activities.


Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Other: EPIC Club Not Applicable

Detailed Description:

Children with poor motor skill acquisition and execution despite having opportunity for learning, are now described as having developmental coordination disorder (DCD). There is a prevalence of 5-6% of young people who have normal intelligence who meet this category who have problems affecting their activities of daily living (ADL's). Young people with lower motor skills are one of a number of conditions affecting children identified by the Chief Medical Officer as requiring an improved evidence base for management. Poor motor skill acquisition and execution, whereby skills remain substantially lower than expected despite opportunities for learning; interferes with participation in academic, sporting and leisure activities. Motor performance is slower and of poor quality; and children may have difficulties learning all kinds of motor skills including sporting activities. Importantly people with poor motor skill acquisition and execution can fail to establish the fundamental movement skills and literacy required to integrate in physical pursuits, such as sport, and become exposed to long-term conditions associated with inactivity. Motor sporting skills can be learnt if trained, but difficulties in performing and learning skills persist into adulthood.

Brain imaging during rhythmic motor tasks which are essential in day-to-day (non-)sporting activities, have established that children with poor motor skill acquisition and execution show differences to healthy controls in grey and white matter functional connectivity and in cortical activation patterns during performance of simple movement tasks . Provisional evidence suggests that individuals with poor motor skill acquisition and execution utilise activation processes when learning motor tasks that are more controlled and require extra processing demands, but a systematic review of neural correlates of those with poor motor skill acquisition and execution concludes that data is scarce and more studies are needed. Performance of motor tasks requires a balance between automatic and controlled processes that is dependent upon the demands of the task and the capabilities of the individual. Young people need to be able to consider their environment when performing a sport rather than just thinking about the skill, so that they can work out where the best place to kick a ball on a football pitch is, not just kick the ball. Typically developing (TDC) children acquire motor skills either implicitly or explicitly by observing and imitating other children and adults or by trial and error. Acquisition of motor tasks requires plasticity in the nervous system with improvements in motor performance underpinned by a move from cortically controlled mechanism, towards more automatic performance, freeing up cortical resources. The ability to automate certain parts of motor skills allows the execution of tasks in more complex environments. Provisional evidence suggests that people with poor motor skill acquisition and execution may learn motor skills in a more controlled manner and have a reduced ability to move automatically. To date no studies have explored the brain changes underpinning fundamental motor skills attainment over a training period in people with poor motor skill acquisition and execution.

The main aim contribute evidence towards describing motor performance in relation to brain structure and functioning in children with lower motor skills and DCD,. This study proposes to test both the feasibility and determine the extent of the impact of learning a novel coordination task on motor performance and brain structure and functioning in children with DCD to inform a full-scale trial of skill acquisition.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Measures taken at Baseline (0 weeks), Post Intervention (6-7 weeks), and follow up (12 weeks)
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Plasticity and Motor Skill Competence Development in Young People With Development Coordination Disorder
Study Start Date : October 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Motor coordination difficulties

Type: Experimental main

EPIC club: 60min session / 2 times weekly / 7 weeks

Other: EPIC Club
Weekly exercise gym sessions. Participants will start with a warm-up of 20-25 mins cardiovascular training either doing cycling, treadmill running or cross-training. The remainder of the session consists of strength/resistance and weight-training involving leg press, leg extensor, pull downs, kettle bells, dumbbells. In addition to the above, a novel rhythmical stepping task will be performed over 10 mins.

Non motor coordination difficulties

Type: Experimental comparator

EPIC club: 60min session / 2 times weekly / 7 weeks

Other: EPIC Club
Weekly exercise gym sessions. Participants will start with a warm-up of 20-25 mins cardiovascular training either doing cycling, treadmill running or cross-training. The remainder of the session consists of strength/resistance and weight-training involving leg press, leg extensor, pull downs, kettle bells, dumbbells. In addition to the above, a novel rhythmical stepping task will be performed over 10 mins.




Primary Outcome Measures :
  1. Novel Stepping Task (assessing change over time) [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    Rhythmic stepping task measuring coordination

  2. Functional Near-Infra red Spectroscopy (FNIRs) (assessing change over time) [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    Monitoring haemodynamic change of the cortex


Secondary Outcome Measures :
  1. Physical Activity Audit (PAQ-A) (assessing change over time) [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    Questionnaire

  2. Functional Magnetic Resonance Imaging (FMRI) (assessing change over time) [ Time Frame: Baseline - change from baseline 6-7 weeks ]
    Monitoring change in brain activity

  3. Movement Assessment Battery for Children 2 [ Time Frame: Baseline ]
    Measuring Motor Coordination

  4. Inertial Measurement Unit (IMU) [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    Accelerometry Gait Analysis

  5. Child Health Utility Questionnaire 9D (assessing change over time) [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    Questionnaire

  6. Harter's Self-Perception Profile for children (assessing change over time) [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    Questionnaire

  7. Axivity AX3 Accelerometer [ Time Frame: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks ]
    7 Day physical activity measurement



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:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 12-15 years old children (year 9 students only) with normal intelligence in the lowest quartile of fitness (30 with poor motor skill acquisition and performance affecting daily functioning, 30 who score in the lower 25% of fitness measures without poor motor skill acquisition and execution).

Exclusion Criteria:

  • Behavioural/intellectual issues that prevent safe participation or may put the participant, investigators and others at risk.
  • Any contraindications to perform maximal exercise or physical training, as determined by the Physical Activity Health Questionnaire PARQ sent out to parents before screening.
  • Children suffering from muscular/neurological degenerative conditions or with uncontrolled epilepsy/seizures (must be stable epilepsy/on medication for greater than 12 weeks).
  • Surgical procedures in the previous 6 months.
  • If there are any concerns regarding a child being able to participate safely, we will ask parents/guardians to contact the GP/paediatrician/physiotherapist.
  • MRI Scanner: children with metal objects due to surgery or dental care cannot partake in the scanning part of the research.

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): NCT03150784


Locations
Layout table for location information
United Kingdom
Cherwell School
Oxford, Oxon, United Kingdom, OX2 7EE
Clinical Exercise Rehabilitation Unit
Oxford, Oxon, United Kingdom, OX3 0BP
Oxford Brookes University
Oxford, Oxon, United Kingdom, OX3 0BP
Cheney School
Oxford, Oxon, United Kingdom, OX3 7QH
Wheatley Park School
Oxford, Oxon, United Kingdom, OX33 1QH
Sponsors and Collaborators
Oxford Brookes University
University of Oxford
National University of Ireland, Maynooth

Layout table for additonal information
Responsible Party: Helen Dawes, Professor, Movement Science Group, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford Brookes University
ClinicalTrials.gov Identifier: NCT03150784     History of Changes
Other Study ID Numbers: 161033
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As per ethical outline, data will not be stored in a shared repository. All data will be stored in an anonymised format on site. Data access requests should be made to the principle investigator in writing which will be discussed in the data monitoring committee meetings.

Keywords provided by Helen Dawes, Oxford Brookes University:
Motor Learning
Coordination
Children
Motor Skills Disorders
Movement

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Ataxia
Motor Skills Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders