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

Primary Purpose

Developmental Coordination Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EPIC Club
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Coordination Disorder focused on measuring Motor Learning, Coordination, Children, Motor Skills Disorders, Movement

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cherwell School
  • Clinical Exercise Rehabilitation Unit
  • Oxford Brookes University
  • Cheney School
  • Wheatley Park School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Motor coordination difficulties

Non motor coordination difficulties

Arm Description

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

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

Outcomes

Primary Outcome Measures

Novel Stepping Task (assessing change over time)
Rhythmic stepping task measuring coordination
Functional Near-Infra red Spectroscopy (FNIRs) (assessing change over time)
Monitoring haemodynamic change of the cortex

Secondary Outcome Measures

Physical Activity Audit (PAQ-A) (assessing change over time)
Questionnaire
Functional Magnetic Resonance Imaging (FMRI) (assessing change over time)
Monitoring change in brain activity
Movement Assessment Battery for Children 2
Measuring Motor Coordination
Inertial Measurement Unit (IMU)
Accelerometry Gait Analysis
Child Health Utility Questionnaire 9D (assessing change over time)
Questionnaire
Harter's Self-Perception Profile for children (assessing change over time)
Questionnaire
Axivity AX3 Accelerometer
7 Day physical activity measurement

Full Information

First Posted
April 4, 2017
Last Updated
May 25, 2018
Sponsor
Oxford Brookes University
Collaborators
University of Oxford, National University of Ireland, Maynooth
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1. Study Identification

Unique Protocol Identification Number
NCT03150784
Brief Title
Rhythmic Motor Learning in Children With Developmental Coordination Disorders
Acronym
EPIC2
Official Title
Brain Plasticity and Motor Skill Competence Development in Young People With Development Coordination Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
Collaborators
University of Oxford, National University of Ireland, Maynooth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
Keywords
Motor Learning, Coordination, Children, Motor Skills Disorders, Movement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Measures taken at Baseline (0 weeks), Post Intervention (6-7 weeks), and follow up (12 weeks)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor coordination difficulties
Arm Type
Experimental
Arm Description
Type: Experimental main EPIC club: 60min session / 2 times weekly / 7 weeks
Arm Title
Non motor coordination difficulties
Arm Type
Other
Arm Description
Type: Experimental comparator EPIC club: 60min session / 2 times weekly / 7 weeks
Intervention Type
Other
Intervention Name(s)
EPIC Club
Intervention Description
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 Measure Information:
Title
Novel Stepping Task (assessing change over time)
Description
Rhythmic stepping task measuring coordination
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks
Title
Functional Near-Infra red Spectroscopy (FNIRs) (assessing change over time)
Description
Monitoring haemodynamic change of the cortex
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks
Secondary Outcome Measure Information:
Title
Physical Activity Audit (PAQ-A) (assessing change over time)
Description
Questionnaire
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks
Title
Functional Magnetic Resonance Imaging (FMRI) (assessing change over time)
Description
Monitoring change in brain activity
Time Frame
Baseline - change from baseline 6-7 weeks
Title
Movement Assessment Battery for Children 2
Description
Measuring Motor Coordination
Time Frame
Baseline
Title
Inertial Measurement Unit (IMU)
Description
Accelerometry Gait Analysis
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks
Title
Child Health Utility Questionnaire 9D (assessing change over time)
Description
Questionnaire
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks
Title
Harter's Self-Perception Profile for children (assessing change over time)
Description
Questionnaire
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks
Title
Axivity AX3 Accelerometer
Description
7 Day physical activity measurement
Time Frame
Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Cherwell School
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX2 7EE
Country
United Kingdom
Facility Name
Clinical Exercise Rehabilitation Unit
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX3 0BP
Country
United Kingdom
Facility Name
Oxford Brookes University
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX3 0BP
Country
United Kingdom
Facility Name
Cheney School
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX3 7QH
Country
United Kingdom
Facility Name
Wheatley Park School
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX33 1QH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Rhythmic Motor Learning in Children With Developmental Coordination Disorders

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