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Trial registered on ANZCTR


Registration number
ACTRN12611000572965
Ethics application status
Approved
Date submitted
24/05/2011
Date registered
3/06/2011
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising motor learning for infants at high risk of cerebral palsy using environmental and goal oriented interventions
Scientific title
What is the effectiveness of using enriched environments and goal directed training compared to standard care to improve motor skills of infants at high risk of cerebral palsy?
Secondary ID [1] 262251 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
GAME study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 267924 0
Condition category
Condition code
Physical Medicine / Rehabilitation 268064 268064 0 0
Physiotherapy
Neurological 268065 268065 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Goal directed training - is a neuroplastic and activity-based approach to rehabilitation.
The therapy approach involves repeated practice of real-life tasks the infant wants to do for example, sitting or reaching for toys. Goal oriented approaches for achieving functional outcomes (sometimes called “functional therapy”) are now widely accepted as best practice for older children with cerebral palsy, are grounded in dynamic systems theory and are supported by Grade A evidence . Influenced by the wealth of literature regarding family centred care, these approaches focus on collaborative goal setting with parents. Goal-limiting factors are identified by holistic assessment of the child, the task being trained and the environment in which learning occurs . An intervention plan is then developed on the basis of the assessment and outcomes evaluated. This approach, has been shown to be effective in adults with acquired brain injury and can be effectively delivered via a home program for older children with cerebral palsy. Enriched home environments are environments where the parent is actively and positively engaged with the child, to facilitate learning. Motor enriched learning environments are created and dynamically adapted so that the appropriate level of learning challenge is provided. Parents are trained in motor task analysis and are coached in appropriate strategies to enhance their child’s development.
Infants in the experimental group for this study will receive the GDT and motor enrichment interventions in a home based setting. Trained therapists will deliver intervention in individual sessions with a parent present. Frequency will be at least fortnightly for approximately 90 minutes each session. In addition, a home programme will be provided.
Intervention code [1] 266619 0
Rehabilitation
Comparator / control treatment
Standard care - describes the current follow-up and/or therapeutic interventions used when an infant deemed at high risk of cerebral palsy is discharged from hospital in NSW Australia.
"Standard care" is extremely varied and ranges from fortnightly visits in a hospital or community health setting to 3 monthly follow ups in a hospital "clinic' setting. Some parents may access private therapy or group based intervention.
In order to monitor the mode, frequency and intensity of intervention received by those in the standard care group, parents will be asked to keep a "log book" so that these relevant parameters can be compared across the groups.
Control group
Active

Outcomes
Primary outcome [1] 289025 0
Peabody Developmental Motor Scale-Second edition
Timepoint [1] 289025 0
Baseline before randomisation, 16 weeks after enrolment, 12 months and 24 months
Secondary outcome [1] 276459 0
Gross motor skills as measured by the Gross Motor Function Measure (GMFM)
Timepoint [1] 276459 0
12 and 24 months only
Secondary outcome [2] 276461 0
Parental stress, depression and anxiety as measured by the Depression and Anxiety Stress Scale (DASS)
Timepoint [2] 276461 0
Baseline before randomisation and 16 weeks post enrolment and at 12 and 24 months after intervention
Secondary outcome [3] 276462 0
Child's performance with goals and parental satisfaction with goal performance as measured by the Canadian Occupational Performance Measure (COPM)
Timepoint [3] 276462 0
Baseline before randomisation and 16 weeks post enrolment and at 12 and 24 months after intervention
Secondary outcome [4] 276576 0
Cognitive and general motor performance as measured by the Bayley Scales of Infant development (Bayleys-III)
Timepoint [4] 276576 0
12 and 24 months
Secondary outcome [5] 301594 0
Affordances in the Home Environment for Motor Development- Infant Scale
Timepoint [5] 301594 0
Baseline before randomisation and at 12 months corrected age
Secondary outcome [6] 301595 0
Hand Assessment of Infants
Timepoint [6] 301595 0
Baseline before randomisation, 16 weeks after enrolment and 12 months of age (corrected).

Eligibility
Key inclusion criteria
1.Diagnosis of Cerebral Palsy or at risk of Cerebral Palsy using Prechtl’s General Movement Assessment (GMs) and confirmatory neuroimaging where available and aged less than 18 weeks post term age OR over 18 weeks and up to 6 months with neuroimaging evidence of brain injury; 2. Parent/guardian consent given 3. Discharged from hospital
Minimum age
9 Weeks
Maximum age
6 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Severe genetic abnormalities as coexisting medical conditions may make participation in the study difficult
2. Not living in a remote location which precludes investigators visiting

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)
Infants will be screened at participating institutions using Prechtl’s General Movement Assessment (GMs). Parents of infants with abnormal general movements will be informed of the results and the eligibility for the trial and invited to give consent to participate. Those consenting will be randomly allocated to one of the 2 groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After informed consent and baseline measures are taken, participants will be randomized by an officer not connected with the study and at a separate location using a pre-prepared random assignment schedule stored within concealed opaque envelopes generated using computer-generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Multiple regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 267117 0
Government body
Name [1] 267117 0
NHMRC
Address [1] 267117 0
GPO Box 1421
Canberra, ACT, 2601


(Scholarship funding only)
Country [1] 267117 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
Research Office
19 Mouat Street,
(PO Box 1225),
Fremantle, WA 6959
Country
Australia
Secondary sponsor category [1] 264210 0
Charities/Societies/Foundations
Name [1] 264210 0
Cerebral Palsy Alliance
Address [1] 264210 0
PO Box 184
Brookvale, NSW, 2100
Country [1] 264210 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267099 0
Cerebral Palsy Alliance Ethics Committee formally known as The Spastic Centre Ethics Committee
Ethics committee address [1] 267099 0
PO Box 184
Brookvale, NSW 2100
Ethics committee country [1] 267099 0
Australia
Date submitted for ethics approval [1] 267099 0
Approval date [1] 267099 0
14/04/2011
Ethics approval number [1] 267099 0
EC00402
Ethics committee name [2] 269123 0
The University of Notre Dame Australia
Ethics committee address [2] 269123 0
The University of Notre Dame Australia
PO Box 1225
Fremantle WA 6959
Ethics committee country [2] 269123 0
Australia
Date submitted for ethics approval [2] 269123 0
Approval date [2] 269123 0
19/04/2011
Ethics approval number [2] 269123 0
011012S
Ethics committee name [3] 288913 0
Sydney Children's Hospital Network HREC
Ethics committee address [3] 288913 0
Locked Bag 4001
Westmead NSW, 2145
Ethics committee country [3] 288913 0
Australia
Date submitted for ethics approval [3] 288913 0
08/03/2013
Approval date [3] 288913 0
15/11/2011
Ethics approval number [3] 288913 0
EC00130

Summary
Brief summary
Infants “at risk” of cerebral palsy (CP) because of premature birth or early brain injury can now be diagnosed early. Early diagnosis allows early intervention to begin at the critical period when the brain is rapidly developing. It has not yet been clearly demonstrated that current early intervention programmes can improve the motor development of infants "at risk" of CP.
"Goal Directed Training" (GDT) is one newer intervention which has been shown to be effective in older children. GDT is based on motor learning principles and involves designing therapy around the family's goals and engaging them to work with their child in their real life environments. A recent systematic review and meta analysis of the effect of environmental enrichment (EE) on infants at high risk of CP demonstrated a small favourable effect for enrichment. Using environmental enrichment strategies, specifically for motor development is a focus of this intervention approach.
Our pilot study (n=13) of 12 weeks of goal directed, motor enrichment intervention demonstrated a significant advantage on the Peabody Developmental Motor Scale for the experimental group.
This study aims to test the effectiveness of GDT and enriched home environments on infants with cerebral palsy. The study is a 2 group RCT (n=30) which compares the effectiveness of GDT and enriched environments with standard care. Participants will be infants 3-6 months of age at enrolment, determined to be at "high risk" of cerebral palsy using the Qualitative Assessment of General Movements (GMs). All infants will receive therapy in this trial until their first birthday. Outcomes of interest include attainment of motor skills, parental emotional well being and quality of the home environment for motor learning.
Trial website
Trial related presentations / publications
1. Morgan C et al. Optimising motor learning in infants pilot study. BMC Pediatrics 2015;15:30.
2. Morgan C et al. GAME (Goals-Activity-Motor-Enrichment): protocol single blind randomised controlled trial of motor training and environmental enrichment. BMC Neuro 2014;14(1):203.
3.Morgan, C. et al. Single blind randomised controlled trial of GAME (Goals-Activity-Motor Enrichment) in infants at high risk of cerebral palsy. Research in developmental disabilities, 2016; 55, 256-267.
Public notes

Contacts
Principal investigator
Name 32642 0
Ms Cathy Morgan
Address 32642 0
Cerebral Palsy Alliance Research Institute, PO Box 184 Brookvale, NSW, 2100
Country 32642 0
Australia
Phone 32642 0
+61 408205542
Fax 32642 0
Email 32642 0
cmorgan@cerebralpalsy.org.au
Contact person for public queries
Name 15889 0
Ms Cathy Morgan
Address 15889 0
PO Box 184
Brookvale, NSW, 2100
Country 15889 0
Australia
Phone 15889 0
+61 408205542
Fax 15889 0
Email 15889 0
cmorgan@cerebralpalsy.org.au
Contact person for scientific queries
Name 6817 0
A/Prof Associate Professor Iona Novak
Address 6817 0
Head of Research | Research Institute
Cerebral Palsy Alliance
School of Medicine | University of Notre Dame Australia
PO Box 560
Darlinghurst NSW1300
Country 6817 0
Australia
Phone 6817 0
+61 409078917
Fax 6817 0
Email 6817 0
inovak@cerebralpalsy.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary