Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000883617
Ethics application status
Approved
Date submitted
21/07/2023
Date registered
16/08/2023
Date last updated
30/08/2024
Date data sharing statement initially provided
16/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Using electroencephalography (EEG) to predict treatment outcomes of a combined action observation and motor imagery intervention on activities of daily living in children with motor and attentional deficits: a multinational study
Scientific title
Using EEG to predict treatment outcomes of a combined action observation and
motor imagery intervention in children with motor and attentional deficits: a multinational study
Secondary ID [1] 310112 0
Funding body: The Waterloo Foundation 2013/5066
Universal Trial Number (UTN)
None
Trial acronym
AOMIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor deficits 330681 0
Condition category
Condition code
Neurological 327499 327499 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Action Observation (AO) and Motor Imagery (MI) Intervention Group: Participants will use a tablet device to watch videos of a child model performing four different movements (cup stacking, tying shoelaces, walking on a curved balance beam, and throwing balls at a target). They will be instructed to observe the action while imagining the associated sensations of that action, and then physically practicing the movement. This will be repeated for 8 minutes per movement, four times a week, for four weeks. The time spent watching each video and physically practicing the movement may vary between children depending on their motor ability - however, in total, they will spend approximately 2-3 minutes watching the videos, and 5-6minutes physically practicing each movement, within the allocated 8 minute period. Participants will not be instructed to practice each movement a certain number of times. They will keep alternating between watching the video and practicing the movement until the end of 8 minutes. They will not be instructed to take any breaks between each movement. Each session will take approximately 32 minutes, for a total of 128 minutes per week (i.e., 32 minutes x 4 sessions per week).

The videos will be created by the research team and filmed from a first/third-person perspective with a typically developing child aged 7 -12 years as the model. The participants will use specific equipment, including the tablet device, provided for the intervention. The intervention will be delivered by the parents/guardians of the child and will be conducted at the participant's home. Parents and children will receive a booklet that includes study-specific questions asking parents/guardians and children to document their performance throughout the intervention (e.g., how motivated they were to complete the training, number of completions/practices they did etc.). Members of the research team will regularly contact the parents via email and zoom video call to promote adherence and answer questions that may arise.
Intervention code [1] 326508 0
Treatment: Other
Intervention code [2] 326509 0
Rehabilitation
Intervention code [3] 326510 0
Behaviour
Comparator / control treatment
Physical Activity Only Group: Participants will engage in physical practice of the four movements (cup stacking, tying shoelaces, walking on a curved balance beam, and throwing balls at a target) for 8 minutes per movement, four times a week, for four weeks. Before each movement, they will play one level of the computer game "Cut the Rope" on the tablet device. This is a child friendly game and involves solving physics-based puzzles. The time spent playing one game level and physically practicing the movement may vary between children depending on their motor ability - however, in total, they will spend approximately 2-3 minutes playing the game, and 5-6minutes physically practicing each movement, within the allocated 8 minute period. Participants will not be instructed to practice each movement a certain number of times. They will keep alternating between playing the game and practicing the movement until the end of 8 minutes. They will not be instructed to take any breaks between each movement. Each session will take approximately 32 minutes, for a total of 128 minutes per week (i.e., 32 minutes x 4 sessions per week).

This will be delivered by the parents/guardians of the child and will be conducted at the participant's home. Parents and children will receive a booklet that includes study-specific questions asking parents/guardians and children to document their performance throughout the intervention (e.g., how motivated they were to complete the training, number of completions/practices they did etc.). Members of the research team will regularly contact the parents via email and zoom video call to promote adherence and answer questions that may arise.
Control group
Active

Outcomes
Primary outcome [1] 335362 0
Task completion time assessed using a digital stopwatch
Timepoint [1] 335362 0
Pre-test (week 0 - prior to commencement of the intervention, primary start point), progress test (2 weeks - post-commencement of intervention), post-test (4 weeks - end of commencement of intervention, primary endpoint), and retention test (6 weeks - 2 weeks post the completion of intervention)
Primary outcome [2] 335429 0
Performance errors on a scale from 1 (task not completed) to 5 (task completed with demonstrated technique).
Timepoint [2] 335429 0
Pre-test (week 0 - prior to commencement of the intervention, primary start point), progress test (2 weeks - post-commencement of intervention), post-test (4 weeks - end of commencement of intervention, primary endpoint), and retention test (6 weeks - 2 weeks post the completion of intervention)
Primary outcome [3] 335718 0
Neural activity recorded during resting state EEG (i.e., frequency bands theta, beta, and alpha)
Timepoint [3] 335718 0
Pre-test (week 0 - prior to commencement of the intervention, primary start point), progress test (2 weeks - post-commencement of intervention), post-test (4 weeks - end of commencement of intervention, primary endpoint), and retention test (6 weeks - 2 weeks post the completion of intervention)
Secondary outcome [1] 424501 0
Qualitative feedback regarding the intervention. This will be received by providing parents/guardians and children with booklets throughout the intervention that contain study-specific questions about their performance. This will also be assessed via a 30 minutes semi-structured interview with the child and their parents/guardians conducted by the member of the research team. These interviews will be audio-recorded
Timepoint [1] 424501 0
At retention test (6 weeks - 2 weeks post the completion of the intervention)

Eligibility
Key inclusion criteria
Children with a prior diagnosis or subclinical levels of Developmental Coordination Disorder (DCD) or co-occurring DCD+Attention Deficit Hyperactivity Disorder (ADHD) aged 7-12 years.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children cannot have a diagnosis of any other neurodevelopmental disorders (e.g., Autism, cerebral palsy) or neurological condition. Children cannot have or indicate typical motor development

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to the intervention or physical activity only control group via minimisation. This method follows a different principle to typical randomisation. Specifically, the initial participant will be randomly allocated to the intervention and physical activity only control group, and then for each subsequent participant allocated, the research team will determine whether or not to allocate the participant to the intervention or physical activity only control group based on different characteristics including diagnosis (i.e., DCD or ADHD+DCD), sex, and age. This will be used in order to achieve a better balance of participant characteristics in the intervention and physical activity only control group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: 40 participants with DCD and 40 participants with DCD+ADHD will be recruited. This is based on replication of the medium effect size observed in a previous pilot study (Scott, M. W., Wood, G., Holmes, P. S., Marshall, B., Williams, J., & Wright, D. J. (2023). Combined action observation and motor imagery improves learning of activities of daily living in children with Developmental Coordination Disorder. Plos one, 18(5), e0284086.) alpha level = .05, power = 80%, 2-tailed.

Data analysis: The following measures will be recorded for each motor task at pre-test (Week 0), progress-test (Week 2), post-test (Week 4) and retention (Week 6): 1) task completion time and 2) number of performance errors. Firstly, separate linear mixed models using restricted maximum likelihood estimation (REML) will be conducted for each motor task, with motor task measure as the dependent variable, and group and time as fixed effects. To examine if any intervention effects generalise to broader motor ability, a linear mixed model will be conducted with motor ability scores as the dependent variable, and with group and time as the fixed effects. Secondly, separate linear mixed models using REML will be conducted for
each EEG frequency band (i.e., delta, theta, alpha, beta, gamma) of resting state EEG recorded for pretest and post-test, with each motor task measure as the dependent variable, and group and frequency band as fixed effects. We are particularly interested in the extent theta, alpha and beta oscillations predict treatment outcomes, since they have previously been implicated in skill acquisition. All models will contain a random intercept to account for repeated observations within participants. Interviews will also be transcribed and analysed thematically.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 25657 0
United Kingdom
State/province [1] 25657 0
Newcastle upon Tyne and Manchester

Funding & Sponsors
Funding source category [1] 314271 0
Charities/Societies/Foundations
Name [1] 314271 0
The Waterloo Foundation (TWF)
Country [1] 314271 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 316288 0
None
Name [1] 316288 0
Address [1] 316288 0
Country [1] 316288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313390 0
The Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 313390 0
Ethics committee country [1] 313390 0
Australia
Date submitted for ethics approval [1] 313390 0
Approval date [1] 313390 0
06/04/2023
Ethics approval number [1] 313390 0
2023-024
Ethics committee name [2] 313440 0
Faculty of Medical Sciences Ethics Committee
Ethics committee address [2] 313440 0
Ethics committee country [2] 313440 0
United Kingdom
Date submitted for ethics approval [2] 313440 0
Approval date [2] 313440 0
06/04/2023
Ethics approval number [2] 313440 0
2493/29368/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127986 0
Dr Pamela Barhoun
Address 127986 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 127986 0
Australia
Phone 127986 0
+61 3 924 68627
Fax 127986 0
Email 127986 0
[email protected]
Contact person for public queries
Name 127987 0
Pamela Barhoun
Address 127987 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 127987 0
Australia
Phone 127987 0
+61 3 924 68627
Fax 127987 0
Email 127987 0
[email protected]
Contact person for scientific queries
Name 127988 0
Pamela Barhoun
Address 127988 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 127988 0
Australia
Phone 127988 0
+61 3 924 68627
Fax 127988 0
Email 127988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval only permits group level data to be shared publicly


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.