- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02904980
The Effects of a Group-based Gaze Training Intervention for Children With Developmental Coordination Disorder
September 13, 2016 updated by: Greg Wood, Manchester Metropolitan University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cheshire
-
Crewe, Cheshire, United Kingdom, CW1 5DU
- Manchester Metropolitan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Score over 5th Percentile on the MABC-2
- Suffers from a neurological disorder
- Below average intelligence
- Any visual impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Technical Training Group
15 children diagnosed with DCD
|
Children will watch an instructional video focused on movement related instructions regarding the throwing and catching task.
|
Experimental: Quiet Eye Training Group
15 children diagnosed with DCD
|
Children will watch the same video as the TT group but will also receive instructions designed to optimise their quiet eye durations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From Baseline to after a 4 week training period, and after 6-week delayed retention test
|
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).
|
From Baseline to after a 4 week training period, and after 6-week delayed retention test
|
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
|
From Baseline to after a 4 week training period, and after 6-week delayed retention test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes 3D Movement Kinematics
Time Frame: From Baseline to after a 4 week training period, and after 6-week delayed retention test
|
Changes in joint angles related to the throwing movement
|
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
|
Changes in muscular activity related to the throwing task
|
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)
|
Parent feedback will be gathered using a short answer questionnaire.
|
End of the study (approximately 12 weeks after baseline testing)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Omid Alizadehkhaiyat, PhD, Liverpool Hope University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Wood 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
September 9, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (Estimate)
September 19, 2016
Study Record Updates
Last Update Posted (Estimate)
September 19, 2016
Last Update Submitted That Met QC Criteria
September 13, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/NW/0279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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