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Developmental Coordination DisorderEPIC2NCT03150784

Rhythmic Motor Learning in Children With Developmental Coordination Disorders

A study testing EPIC Club in people with Developmental Coordination Disorder, run by Oxford Brookes University at 5 sites in United Kingdom.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Developmental Coordination Disorder
What is being tested?
EPIC Club
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
5 sitesUnited Kingdom
Study dates
Oct 2016to Aug 2018
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 12 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites
  • Cherwell School

    Oxford, OXON, OX2 7EE

  • Clinical Exercise Rehabilitation Unit

    Oxford, OXON, OX3 0BP

  • Oxford Brookes University

    Oxford, OXON, OX3 0BP

  • Cheney School

    Oxford, OXON, OX3 7QH

  • Wheatley Park School

    Oxford, OXON, OX33 1QH

Other trials in United Kingdom

About this study

Official title: Brain Plasticity and Motor Skill Competence Development in Young People With Development Coordination Disorder

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.

Read the 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.

Being tested
EPIC Club
Keywords
Motor Learning, Coordination, Children, Motor Skills Disorders, Movement
Medical subject headings
Motor Skills Disorders

What participants receive

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

  • EPIC ClubOther

    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.

Study groups in NCT03150784
Study groupRoleWhat they receive
Motor coordination difficultiesExperimentalType: Experimental main EPIC club: 60min session / 2 times weekly / 7 weeks
Receives: Other: EPIC Club
Non motor coordination difficultiesOtherType: Experimental comparator EPIC club: 60min session / 2 times weekly / 7 weeks
Receives: Other: EPIC Club

What is being measured

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

  1. Novel Stepping Task (assessing change over time)

    Rhythmic stepping task measuring coordination

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

  2. Functional Near-Infra red Spectroscopy (FNIRs) (assessing change over time)

    Monitoring haemodynamic change of the cortex

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

Secondary outcomes (7)
  1. Physical Activity Audit (PAQ-A) (assessing change over time)

    Questionnaire

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

  2. Functional Magnetic Resonance Imaging (FMRI) (assessing change over time)

    Monitoring change in brain activity

    Measured: Baseline - change from baseline 6-7 weeks

  3. Movement Assessment Battery for Children 2

    Measuring Motor Coordination

    Measured: Baseline

  4. Inertial Measurement Unit (IMU)

    Accelerometry Gait Analysis

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

  5. Child Health Utility Questionnaire 9D (assessing change over time)

    Questionnaire

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

  6. Harter's Self-Perception Profile for children (assessing change over time)

    Questionnaire

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 12 weeks

  7. Axivity AX3 Accelerometer

    7 Day physical activity measurement

    Measured: Baseline - change from baseline 6-7 weeks - change from baseline 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 posted12 May 2017
  2. Study startOct 2016
  3. Primary completionAug 2018 (estimated)
  4. Study completionAug 2018 (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
Basic science
Allocation
Non-randomised
Intervention model
Single group
Model description
Measures taken at Baseline (0 weeks), Post Intervention (6-7 weeks), and follow up (12 weeks)
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150784
Sponsor's protocol ID
161033
Acronym
EPIC2
Status last verified
May 2018
First submitted
4 Apr 2017
Last updated
30 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: 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.

Publications

  • Liu YC, Esser P, Weedon BD, Springett D, Joshi S, Tsou MH, Wang RY, Dawes H. Knee joint position sense and kinematic control in relation to motor competency in 13 to 14-year-old adolescents. Ital J Pediatr. 2024 Sep 29;50(1):200. doi: 10.1186/s13052-024-01765-z.

    PubMed 39343969
  • Inacio M, Esser P, Weedon BD, Joshi S, Meaney A, Delextrat A, Springett D, Kemp S, Ward T, Izadi H, Johansen-Berg H, Dawes H. Learning a novel rhythmic stepping task in children with probable developmental coordination disorder. Clin Biomech (Bristol). 2023 Feb;102:105904. doi: 10.1016/j.clinbiomech.2023.105904. Epub 2023 Feb 3.

    PubMed 36764101

Questions about this trial

What is this clinical trial studying?

A study testing EPIC Club in people with Developmental Coordination Disorder, run by Oxford Brookes University at 5 sites in United Kingdom.

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 1 inclusion and 6 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Novel Stepping Task (assessing change over time) (time frame: Baseline - change from baseline 6-7 weeks - change from baseline 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 NCT03150784, which also lists 2 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 30 May 2018.

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