Developmental Coordination DisorderNCT02904980
The Effects of a Group-based Gaze Training Intervention for Children With Developmental Coordination Disorder
A study testing Technical Training and Quiet Eye Training in people with Developmental Coordination Disorder, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
The aim of this study was to integrate a gaze training intervention (i.e., quiet eye training; QET) that has been shown to improve the throwing and catching skill of children with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that might alleviate the psychosocial influence of… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Technical Training and Quiet Eye Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Sep 2015
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Prior diagnosis of Developmental Coordination Disorder or suspected to have DCD
- Scores below the 5th percentile on the MABC-2 (Movement Assessment Battery for Children-2)
- Be of normal intelligence (assessed through parent/teacher feedback)
- No neurological disorder
- Normal of corrected-to-normal vision
Who cannot join
- Score over 5th Percentile on the MABC-2
- Suffers from a neurological disorder
- Below average intelligence
- Any visual impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Metropolitan University
Crewe, Cheshire, CW1 5DU
About this study
Official title: A Randomised Controlled Trial of a Group-based, Gaze Training Intervention for Children With Developmental Coordination Disorder
The aim of this study was to integrate a gaze training intervention (i.e., quiet eye training; QET) that has been shown to improve the throwing and catching skill of children with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that might alleviate the psychosocial influence of these motor skill deficits.
Read the detailed description
Children with DCD will be randomly split into either QET group or a technical training (TT). The TT group will be given movement-related instructions via video, relating to the throw and catch phases, while the QET group will also be taught to fixate a target location on the wall prior to the throw (QE1) and to track the ball prior to the catch (QE2). Each group will take part in a 4- week, group therapy intervention and measurements of QE duration obtained from a mobile eye tracking system and catching performance are to be taken before and after training, and at a 6-week delayed retention test. Parental feedback on psychosocial and motor skill outcomes will also be collected at delayed retention.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Technical Training, Quiet Eye Training
- Keywords
- Quiet eye training, Visual Attention
- 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.
Technical TrainingBehavioural
Children will watch an instructional video focused on movement related instructions regarding the throwing and catching task.
Quiet Eye TrainingBehavioural
Children will watch the same video as the TT group but will also receive instructions designed to optimise their quiet eye durations.
| Study group | Role | What they receive |
|---|---|---|
| Technical Training Group | Experimental | 15 children diagnosed with DCD Receives: Behavioral: Technical Training |
| Quiet Eye Training Group | Experimental | 15 children diagnosed with DCD Receives: Behavioral: Quiet Eye Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Catching Success
How many balls the participants catch out of 50 attempts
Measured: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Changes in the qualitative catching performance scale score
The qualitative catching performance scale consisted of an 11-point scale whereby catch attempts were given a score between '0' (Makes no move towards the ball as it comes back) and '10' (The catch is made exclusively with the palms and fingers).
Measured: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Changes in Quiet Eye durations
Changes in participants eye-movements
Measured: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Secondary outcomes (3)
Changes 3D Movement Kinematics
Changes in joint angles related to the throwing movement
Measured: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Changes in Muscular Activity (EMG)
Changes in muscular activity related to the throwing task
Measured: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Parental Perceptions of Motor Skill Improvements
Parent feedback will be gathered using a short answer questionnaire.
Measured: End of the study (approximately 12 weeks after baseline testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Hope University, University of Exeter, University of Calgary, The Waterloo Foundation
- Responsible party
- Principal investigator, Greg Wood, Manchester Metropolitan University
- Investigators
- Omid Alizadehkhaiyat, PhD, Study director, Liverpool Hope University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904980
- Sponsor's protocol ID
- 15/NW/0279
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Miles CA, Wood G, Vine SJ, Vickers JN, Wilson MR. Quiet eye training facilitates visuomotor coordination in children with developmental coordination disorder. Res Dev Disabil. 2015 May;40:31-41. doi: 10.1016/j.ridd.2015.01.005. Epub 2015 Feb 25.
PubMed 25721344Wood G, Miles CA, Coyles G, Alizadehkhaiyat O, Vine SJ, Vickers JN, Wilson MR. A randomized controlled trial of a group-based gaze training intervention for children with Developmental Coordination Disorder. PLoS One. 2017 Feb 10;12(2):e0171782. doi: 10.1371/journal.pone.0171782. eCollection 2017.
PubMed 28187138
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Group-based, Gaze Training Intervention for Children With Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT02904980
- Acronym / sponsor ID
- 15/NW/0279
- Conditions
- Developmental Coordination Disorder
- Keywords
- Quiet eye training, Visual Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Liverpool Hope University, University of Exeter, University of Calgary, The Waterloo Foundation
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to integrate a gaze training intervention (i.e., quiet eye training; QET) that has been shown to improve the throwing and catching skill of children with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that might alleviate the psychosocial influence of these motor skill deficits.
Detailed description
Children with DCD will be randomly split into either QET group or a technical training (TT). The TT group will be given movement-related instructions via video, relating to the throw and catch phases, while the QET group will also be taught to fixate a target location on the wall prior to the throw (QE1) and to track the ball prior to the catch (QE2). Each group will take part in a 4- week, group therapy intervention and measurements of QE duration obtained from a mobile eye tracking system and catching performance are to be taken before and after training, and at a 6-week delayed retention test. Parental feedback on psychosocial and motor skill outcomes will also be collected at delayed retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technical Training Group | Experimental | Behavioral: Technical Training15 children diagnosed with DCD |
| Quiet Eye Training Group | Experimental | Behavioral: Quiet Eye Training15 children diagnosed with DCD |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Prior diagnosis of Developmental Coordination Disorder or suspected to have DCD
- Scores below the 5th percentile on the MABC-2 (Movement Assessment Battery for Children-2)
- Be of normal intelligence (assessed through parent/teacher feedback)
- No neurological disorder
- Normal of corrected-to-normal vision
Key exclusion criteria (4 listed)
- Score over 5th Percentile on the MABC-2
- Suffers from a neurological disorder
- Below average intelligence
- Any visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technical TrainingChildren will watch an instructional video focused on movement related instructions regarding the throwing and catching task. | Behavioural | Technical Training Group |
| Quiet Eye TrainingChildren will watch the same video as the TT group but will also receive instructions designed to optimise their quiet eye durations. | Behavioural | Quiet Eye Training Group |
Primary outcome
Change in Catching Success
Time frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test
How many balls the participants catch out of 50 attempts
Changes in the qualitative catching performance scale score
Time frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test
The qualitative catching performance scale consisted of an 11-point scale whereby catch attempts were given a score between '0' (Makes no move towards the ball as it comes back) and '10' (The catch is made exclusively with the palms and fingers).
Changes in Quiet Eye durations
Time frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Changes in participants eye-movements
3 secondary outcomes
Changes 3D Movement Kinematics
Time frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Changes in Muscular Activity (EMG)
Time frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test
Parental Perceptions of Motor Skill Improvements
Time frame: End of the study (approximately 12 weeks after baseline testing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Background: PubMed 25721344Miles CA, Wood G, Vine SJ, Vickers JN, Wilson MR. Quiet eye training facilitates visuomotor coordination in children with developmental coordination disorder. Res Dev Disabil. 2015 May;40:31-41. doi: 10.1016/j.ridd.2015.01.005. Epub 2015 Feb 25.
- Derived from this study: PubMed 28187138Wood G, Miles CA, Coyles G, Alizadehkhaiyat O, Vine SJ, Vickers JN, Wilson MR. A randomized controlled trial of a group-based gaze training intervention for children with Developmental Coordination Disorder. PLoS One. 2017 Feb 10;12(2):e0171782. doi: 10.1371/journal.pone.0171782. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omid Alizadehkhaiyat, PhD study director
Liverpool Hope University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technical Training and Quiet Eye Training in people with Developmental Coordination Disorder, run by Manchester Metropolitan University at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Catching Success (time frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test). The study lists 3 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 NCT02904980, 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 19 Sep 2016.