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Trial registered on ANZCTR


Registration number
ACTRN12614000314628
Ethics application status
Approved
Date submitted
5/03/2014
Date registered
25/03/2014
Date last updated
6/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Discovering the sense of touch- sensory discrimination training for children with cerebral palsy
Scientific title
The effect of sensory discrimination training compared to no treatment on sensory discrimination in children with cerebral palsy.
Secondary ID [1] 283631 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy
 290570 0
Impaired somatosensory discrimination 290571 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290964 290964 0 0
Occupational therapy
Neurological 290965 290965 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive sensory discrimination training- one hour three times a week for six weeks. Sensory discrimination training is administered one to one with an occupational therapist and involves the progression through graded stimuli from the greatest differences to finer differences in texture discrimination, object recognition and body position sense. These sub- components of training are also integrated into a client selected goal.
Intervention code [1] 288329 0
Rehabilitation
Comparator / control treatment
A control group of children with hemiplegic cerebral palsy receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 290947 0
sense_assess for kids- sensory discrimination measure
Timepoint [1] 290947 0
Baseline, post treatment, 6 weeks follow-up and 6 months follow-up
Primary outcome [2] 290948 0
Changes in occupational performance are being measured using the COPM and GAS
Timepoint [2] 290948 0
Baseline, Post treatment, 6 weeks follow-up and 6 months follow-up
Secondary outcome [1] 305652 0
Changes in aspects of activity performance will be measured using the AHA and the box and blocks test.
Timepoint [1] 305652 0
Baseline, post treatment, 6 weeks follow-up and 6 months follow-up

Eligibility
Key inclusion criteria
Diagnosis of Cerebral palsy
Hemiplegia
Reduced sensation as measured by the sense_assess
Aged 5-15yrs
Sufficient concentration to complete assessment
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absence of sensory deficit

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)
The CI contacts families to conduct initial assessment, once sensory capacity is known children are randomised to treatment or control group using central randomisation (computer) by a person not involved with this trial. The assessor determining eligibility of participants is not informed of group allocation at any point in time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children in this study are matched on age and MACS level.
The first child to enter the study without an existing match is randomised, the first child who is a match for age and MACS is automatically allocated to the other group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multiple time-point ANOVA using intention to treat analysis.

Data from Carey et al., (2011) intervention study with adults post-stroke was used to determine sample size and effect size. This data was used because this study is trialling the same treatment outlined in Carey's work but with children. Means and standard deviations for the experimental and control groups at baseline and the end of phase one were used. Experimental group baseline: -41.14 (35.79) and end of phase one: -18.78 (40.92); the control group baseline: -31.24 (27.07) and end of phase one: -26.61 (33.54). The calculated power is .95 with an effect size of 1.213 and a sample size of 32 participants.

Carey, L., Macdonell, R., & Matyas, T. A. (2011). SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation: A Randomized Controlled Trial. Neurorehabilitation and Neural Repair, 25(4), 304-313. doi: 10.1177/1545968310397705

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2013
Actual
3/06/2013
Date of last participant enrolment
Anticipated
30/11/2018
Actual
28/01/2015
Date of last data collection
Anticipated
Actual
15/10/2015
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1755 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 6486 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 14049 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 288317 0
University
Name [1] 288317 0
University of Western Australia
Country [1] 288317 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 287034 0
University
Name [1] 287034 0
School of Paediatrics and Child Health
University of Western Australia
Address [1] 287034 0
Roberts Road
Subiaco WA 6008
Country [1] 287034 0
Australia
Other collaborator category [1] 277709 0
University
Name [1] 277709 0
Florey Neuroscience Institute
Melbourne Brain Centre
University of Melbourne
Address [1] 277709 0
Melbourne Brain Centre
University of Melbourne
Austin Campus
245 Burgundy Street
Heidlberg VIC 3084
Country [1] 277709 0
Australia
Other collaborator category [2] 277861 0
University
Name [2] 277861 0
Curtin University of Technology
School of Occupational Therapy and Social Work
Address [2] 277861 0
Kent Street,
Bentley WA 6102
Country [2] 277861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290212 0
Princess Margaret Hospital HREC
Ethics committee address [1] 290212 0
Roberts Rd
Subiaco WA 6008
Ethics committee country [1] 290212 0
Australia
Date submitted for ethics approval [1] 290212 0
15/11/2012
Approval date [1] 290212 0
29/07/2016
Ethics approval number [1] 290212 0
2052
Ethics committee name [2] 295736 0
Princess Margaret Hospital HREC
Ethics committee address [2] 295736 0
Roberts Road, Subiaco WA 6008
Ethics committee country [2] 295736 0
Australia
Date submitted for ethics approval [2] 295736 0
Approval date [2] 295736 0
17/04/2014
Ethics approval number [2] 295736 0
2014034

Summary
Brief summary
This study aims to find out if a sensory discrimination training method that is effective in reducing sensory impairment in adults who have had a stroke is also effective in reducing impairments in sensation for children with cerebral palsy.

We hypothesise that sensory discrimination training will improve sensory discrimination for children with hemiplegic cerebral palsy and result in improvements in function, activity and quality of life. Additionally we hypothesis that central changes will be evident on fMRI following intervention. We hypothesise that changes will be sustained at 6 months post intervention.
Trial website
N/A
Trial related presentations / publications
McLean, B., Taylor, S., Blair, E., Valentine, J., Carey, L., Elliott, C. (2017). Somatosensory discrimination intervention improves body position sense and motor performance in children with hemiplegic cerebral palsy. The American Journal of Occupational Therapy, 71(3), 7103190060p1-7103190060p9.
Public notes

Contacts
Principal investigator
Name 44470 0
Ms Belinda McLean
Address 44470 0
Department of Paediatric Rehabilitation
Princess Margaret Hospital
37-39 Hay Street
Subiaco WA 6008
Country 44470 0
Australia
Phone 44470 0
+61403961217
Fax 44470 0
+61 8 9380 2119
Email 44470 0
[email protected]
Contact person for public queries
Name 44471 0
Dr Ashleigh Thornton
Address 44471 0
Department of Paediatric Rehabilitation
Princess Margaret Hospital
37-39 Hay Street
Subiaco WA 6008
Country 44471 0
Australia
Phone 44471 0
+61 8 9380 2119
Fax 44471 0
+61 8 9381 2990
Email 44471 0
[email protected]
Contact person for scientific queries
Name 44472 0
Dr Belinda McLean
Address 44472 0
Department of Paediatric Rehabilitation
Princess Margaret Hospital
37-39 Hay Street
Subiaco WA 6008
Country 44472 0
Australia
Phone 44472 0
+61 8 9380 2119
Fax 44472 0
+61 8 9380 2119
Email 44472 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

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