NCT03150784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

April 4, 2017

Last Update Submit

May 25, 2018

Conditions

Keywords

Motor LearningCoordinationChildrenMotor Skills DisordersMovement

Outcome Measures

Primary Outcomes (2)

  • Novel Stepping Task (assessing change over time)

    Rhythmic stepping task measuring coordination

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

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

    Monitoring haemodynamic change of the cortex

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

Secondary Outcomes (7)

  • Physical Activity Audit (PAQ-A) (assessing change over time)

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

  • Functional Magnetic Resonance Imaging (FMRI) (assessing change over time)

    Baseline - change from baseline 6-7 weeks

  • Movement Assessment Battery for Children 2

    Baseline

  • Inertial Measurement Unit (IMU)

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

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

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

  • +2 more secondary outcomes

Study Arms (2)

Motor coordination difficulties

EXPERIMENTAL

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

Other: EPIC Club

Non motor coordination difficulties

OTHER

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

Other: EPIC Club

Interventions

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.

Motor coordination difficultiesNon motor coordination difficulties

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cherwell School

Oxford, OXON, OX2 7EE, United Kingdom

Location

Clinical Exercise Rehabilitation Unit

Oxford, OXON, OX3 0BP, United Kingdom

Location

Oxford Brookes University

Oxford, OXON, OX3 0BP, United Kingdom

Location

Cheney School

Oxford, OXON, OX3 7QH, United Kingdom

Location

Wheatley Park School

Oxford, OXON, OX33 1QH, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Measures taken at Baseline (0 weeks), Post Intervention (6-7 weeks), and follow up (12 weeks)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Movement Science Group, Faculty of Health and Life Sciences, Oxford Brookes University

Study Record Dates

First Submitted

April 4, 2017

First Posted

May 12, 2017

Study Start

October 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

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.

Locations