Trial Review

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
ACTRN12611000991910
Ethics application status
Approved
Date submitted
5/09/2011
Date registered
16/09/2011
Date last updated
16/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Upper limb - Baby Early Action-observation Training: Randomised trial of the effect of infant action observation training on the early development of hand reaching and grasping in healthy infants and in infants with early brain injury.
Scientific title
Randomised trial of the effect of infant action observation training on the early development of hand reaching and grasping in healthy infants and in infants with early brain injury.
Secondary ID [1] 262986 0
Nil.
Universal Trial Number (UTN)
Nil.
Trial acronym
UP-BEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asymmetric brain lesions 270709 0
Venous infarction 270710 0
Arterial stroke 270711 0
Congenital hemiplegia 270712 0
Condition category
Condition code
Neurological 270887 270887 0 0
Other neurological disorders
Stroke 270888 270888 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Action Observation Training is performed by a parent/caregiver of each infant in this cohort for 4 weeks; from 9 to 13 post-term weeks of age, for 6 days per week. Three sessions of 5 minutes are performed each day, for a total daily training dose of 15 minutes. Each session involves the parent/caregiver showing the baby the action of repeatedly grasping a toy. There is a set of 3 toys presented in a random order, and the time is monitored on a stopwatch. If the infant stops attending, the timer is stopped and the baby is allowed to grasp and play with the toy for a short period. The session can then recommence and the timer started again so that they baby has a full 5 minutes of training. The total dose of training over the 4 weeks is 6 hours.
Intervention code [1] 269330 0
Treatment: Other
Intervention code [2] 269331 0
Rehabilitation
Comparator / control treatment
Toy Observation Training is performed by a parent/caregiver of each infant in this cohort for 4 weeks; from 9 to 13 post-term weeks of age, for 6 days per week. Three sessions of 5 minutes are performed each day, for a total daily training dose of 15 minutes. Each session involves the parent/caregiver showing the baby a toy (without grasping). There is a set of 3 toys presented in a random order, and the time is monitored on a stopwatch. If the infant stops attending, the timer is stopped and the baby is allowed to grasp and play with the toy for a short period. The session can then recommence and the timer started again so that they baby has a full 5 minutes of training. The total dose of training over the 4 weeks is 6 hours.
Control group
Active

Outcomes
Primary outcome [1] 279566 0
Symmetry of reaching and grasping, using the Infant Hand Assessment
Timepoint [1] 279566 0
18 weeks
Primary outcome [2] 279641 0
Quantity and quality of reaching and grasping, using the Reach and Grasp Assessment
Timepoint [2] 279641 0
18 weeks
Secondary outcome [1] 287905 0
Pressure of grasping, using a customised pressure sensor
Timepoint [1] 287905 0
18 weeks
Secondary outcome [2] 287906 0
Cognitive and Motor development, using the Bayley Developmental Scales (version III)
Timepoint [2] 287906 0
6 months
Secondary outcome [3] 287907 0
Brain activity related to action observation, using an Electroencephalogram (EEG)
Timepoint [3] 287907 0
6 months
Secondary outcome [4] 294109 0
Cognitive and Motor development, using the Bayley Developmental Scales (version III)
Timepoint [4] 294109 0
12 months

Eligibility
Key inclusion criteria
Healthy term group:
- Gestational age at birth between 38 and 41 weeks
- Uncomplicated delivery
- Absence of post-natal complications
- Lives within 50km of RCH
- Parents willing and available to participate up to their baby’s 12mth assessment

Asymmetric brain lesion group:
- Presence of a unilateral or asymmetric brain damage (i.e. preterm or term arterial stroke, unilateral grade IV intraventricular haemorrhage, unilateral periventricular leukomalacia) on neonatal ultrasound or MRI
- Lives within 200km of RCH and could be visited at home
Minimum age
0 Years
Maximum age
9 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Healthy term group:
- a complicated delivery
- post-natal complications (e.g. asphyxia)

Asymmetric brain lesion group:
- epileptic seizures unresponsive to treatment

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 within each group are randomised to receive either Action Observation Training or Toy Observation Training.
Allocation is carried out in concealed envelopes, opened by non-study personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised sequence is generated by computer-generated numbers placed in concealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269795 0
Government body
Name [1] 269795 0
Australian Research Council (Discovery Grant)
Country [1] 269795 0
Australia
Funding source category [2] 269796 0
University
Name [2] 269796 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (Funding)
Country [2] 269796 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Roslyn Boyd
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre,
Level 7, Block 6, Royal Brisbane and Women's Hospital, Herston, QLD 4029
Country
Australia
Secondary sponsor category [1] 268829 0
None
Name [1] 268829 0
Address [1] 268829 0
Country [1] 268829 0
Other collaborator category [1] 252249 0
Individual
Name [1] 252249 0
Dr Andrea Guzzetta
Address [1] 252249 0
Department of Developmental Neuroscience,
Stella Maris Scientific Institute,
Via dei Giacinti, 2 I-56018
Calambrone, Pisa, Italy.
Country [1] 252249 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271751 0
The University of Queensland, Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 271751 0
The Office of Research and Postgraduate Studies,
Cumbrae-Stewart Building (72),
The University of Queensland,
St Lucia, QLD, 4072
Ethics committee country [1] 271751 0
Australia
Date submitted for ethics approval [1] 271751 0
Approval date [1] 271751 0
08/12/2009
Ethics approval number [1] 271751 0
2009001870
Ethics committee name [2] 271752 0
The Royal Children's Hospital Queensland Children's Health Services District (RCH) Ethics Committee
Ethics committee address [2] 271752 0
Level 3, Foundation Building,
Royal Children's Hospital,
Herston, QLD, 4029
Ethics committee country [2] 271752 0
Australia
Date submitted for ethics approval [2] 271752 0
Approval date [2] 271752 0
08/12/2009
Ethics approval number [2] 271752 0
HREC/09/QRCH/134
Ethics committee name [3] 271753 0
The Royal Brisbane & Women's (RBWH) Hospital Human Research Ethics Committee
Ethics committee address [3] 271753 0
Human Research Ethics Office,
Level 7, Block 7,
Royal Brisbane & Women's Hospital,
Metro North Health Service District,
Herston, QLD, 4029
Ethics committee country [3] 271753 0
Australia
Date submitted for ethics approval [3] 271753 0
Approval date [3] 271753 0
20/04/2011
Ethics approval number [3] 271753 0
HREC/09/QRCH/134

Summary
Brief summary
This project aims to explore, in a randomised trial, whether a novel training program based on the observation of hand action can influence the early development of hand reaching and grasping in healthy infants and infants with asymmetric brain injury. This study will compare Action Observation Training with standard Observation Training in a population of healthy term infants, as well as in a population of infants with asymmetric brain injury.

It is predicted that:
(1) Action Observation Training will improve the symmetry of bimanual hand function as measured on the Infant Hand Assesment at 18 weeks, compared to standard Observation Training; and
(2) Action Observation Training will have a greater impact on the quantity and quality of reaching and grasping of the impaired hand as measured on the Reach and Grasp Assessment at 18 weeks, compared to standard Observation Training.
Trial website
http://www2.som.uq.edu.au/som/Research/ResearchCentres/qcprrc/projects/Pages/Up-Beat.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33115 0
Address 33115 0
Country 33115 0
Phone 33115 0
Fax 33115 0
Email 33115 0
Contact person for public queries
Name 16362 0
Associate Professor Roslyn Boyd
Address 16362 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC),
Level 7, Block 6,
Royal Brisbane & Women's Hospital,
Cnr Butterfield and Bowen Bridge Rd,
Herston, QLD, 4029
Country 16362 0
Australia
Phone 16362 0
+61434608443
Fax 16362 0
Email 16362 0
[email protected]
Contact person for scientific queries
Name 7290 0
Associate Professor Roslyn Boyd
Address 7290 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC),
Level 7, Block 6,
Royal Brisbane & Women's Hospital,
Cnr Butterfield and Bowen Bridge Rd,
Herston, QLD, 4029
Country 7290 0
Australia
Phone 7290 0
+61434608443
Fax 7290 0
Email 7290 0
[email protected]

No information has been provided regarding IPD availability


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.