Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000348257
Ethics application status
Approved
Date submitted
2/03/2018
Date registered
8/03/2018
Date last updated
8/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Discovering the sense of touch- somatosensory discrimination training for children with cerebral palsy
Scientific title
Discovering the sense of touch: A randomised controlled trial examining the efficacy of a somatosensory discrimination intervention for children with hemiplegic cerebral palsy
Secondary ID [1] 294217 0
None
Universal Trial Number (UTN)
U1111-1210-1726
Trial acronym
Linked study record
Feasibility trial for this work is: ACTRN12614000314628 and those findings have been published: 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

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 306874 0
Hemiplegia 306875 0
Impaired tactile discrimination 306876 0
Impaired haptic object recognition 306877 0
Impaired limb position 306878 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305975 305975 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Sense© for Kids

Procedures: Sense© for Kids addresses somatosensory discrimination functions through implementation of the following essential elements-
• Active exploration without vision of new and known stimuli where the child explores objects/textures/body positions with focus on discriminating differences.
• Anticipation is used for previously experienced stimuli; the child knows what to expect to feel and concentrates on attributes of difference without vision.
• Calibration occurs within and across modalities with comparison of what is felt by the impaired hand with the less affected hand and with vision. The child matches what they know from visual confirmation and calibration with the less affected hand with their impaired hand. They are prompted to imagine what the sensory stimulus is supposed to feel like based on this knowledge.
• Each level of stimulus difference is trained to an accuracy level of 75% correct responses before progressing to a more difficult level of difference.
• Transfer to untrained tasks is facilitated by training on a large variety of stimuli and integrating training principles into occupational tasks important the child. Occupational tasks are trained using grading of stimuli, feedback on distinctive features of difference and method of exploration. Additional information can be found in SENSe: A Manual for Therapists.
Carey L: SENSe: Helping stroke survivors regain a sense of touch: A Manual and DVD for therapists. Melbourne, VIC, Australia: Florey Institute of Neuroscience and Mental Health; 2012..

Who: Sense© for Kids will be administered by an occupational therapist with a minimum of 5 years experience.

Mode of delivery: Face to face individual therapy sessions.

Duration/ dose/ intensity: Children will receive three hours a week for six weeks amounting to 18 hours of total intervention. Two hours per week will be therapist-led, a cumulative one hour per week will be parent-led.

Location: In the participants home.

Tailoring: Because children will set their own goals, the activities pertaining to the goal itself may differ but in all other aspects this intervention will remain the same for all participants.

Fidelity: This study seeks to define and measure fidelity of Sense© for Kids for clinician adherence to the active ingredients and intervention receipt. A treatment fidelity checklist has been developed and will be published with the study protocol.
Intervention code [1] 300509 0
Rehabilitation
Comparator / control treatment
Brief name: Goal Directed Training via Home Programme

Procedures: Goal Directed Training via Home Programme addresses goal performance through implementation of the following essential elements-
Goal Directed Training essential elements:
- Caregiver and child set goals about real-life activities the child wants or needs to perform and determines with the therapist which are realistic for intervention.
- Examination of the goal-limiting factors at the child, task and environment level.
- Changing the task and environment to facilitate child-active independence task performance.
- Establishment of a child-active motor practice schedule based on current motor performance, including intense repetition, variation and structured feedback.
Home Program Essential Elements:
- Development of a collaborative partnership characterised by empowerment of parents
- Therapist takes on a coaching role in partnership with the parent as the expert in their unique context
- Goals are set by the child and parent
- A menu of tasks to practice using Goal Directed Training principles are provided to support home practice
- Therapists actively support implementation to ensure the program continues to meet family needs and help identify successes.

Who: Goal Directed Training via Home Programme will be administered by an occupational therapist with a minimum of 5 years experience.

Mode of delivery: Face to face individual therapy sessions.

Duration/ dose/ intensity: Children will receive three hours a week for six weeks amounting to 18 hours of total intervention. One hour per week will be therapist-led, a cumulative two hours per week will be parent-led.

Location: In the participants home

Tailoring: Because children will set their own goals, the activities pertaining to the goal itself may differ but in all other aspects this intervention will remain the same for all participants.

Fidelity: This study seeks to define and measure fidelity of Goal Directed Therapy via Home Programmes for clinician adherence to the active ingredients and intervention receipt. A treatment fidelity checklist has been developed and will be published with the study protocol.
Control group
Active

Outcomes
Primary outcome [1] 305008 0
sense©_assess kids- sensory discrimination measure
Timepoint [1] 305008 0
Baseline, at the completion of a 6 week course of intervention (primary endpoint), 6 weeks , 6 months and 12 months after completion of intervention to observe maintenance of any change.
Primary outcome [2] 305009 0
Functional Magenetic Resonance Imaging will be used to measure changes in neural pathways following treatment.
Timepoint [2] 305009 0
Baseline, at the completion of a 6 week course of intervention (primary endpoint), 6 months and 12 months after completion of intervention to observe maintenance of any change.
Secondary outcome [1] 343860 0
Changes in aspects of activity performance will be measured using the Assisting Hand Assessment.
Timepoint [1] 343860 0
Baseline, at the completion of a 6 week course of intervention, 6 weeks , 6 months and 12 months after completion of intervention to observe maintenance of any change.
Secondary outcome [2] 343861 0
Changes in occupational performance are being measured using the Canadian Occupational Performance Measure and Goal Attainment Scaling
Timepoint [2] 343861 0
Baseline, at the completion of a 6 week course of intervention, 6 weeks , 6 months and 12 months after completion of intervention to observe maintenance of any change.

Eligibility
Key inclusion criteria
Diagnosis of Cerebral palsy
Hemiplegia
Somatosensory discrimination impairment as measured by the sense_assess
Aged 8-15yrs
Sufficient concentration to complete assessment
Minimum age
8 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absence of somatosensory impairment
fMRI safety exclusion criteria (metal implants and implantable devices; significant anxiety or behavioural problems; claustraphobia)

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 will involve central randomisation by online computer form by a staff member not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation. Participants will be matched for age (+/- 6 months) and somatosensory capacity composite score to minimise the effect of heterogeneity in this population. When a participant is enrolled to the study without a match for age and somatosensory capacity, that child will be randomly allocated to a treatment group using an online randomisation form by a staff member not involved in the study. The next child enrolled who is a match for the unmatched participant will be automatically allocated to the alternate group. The process will be repeated for each matched pair; the first member always being allocated at random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine the sample size we used pilot data from seven children with HCP who received the intervention. Data from the Wrist Position Sense Test (a component of the sense©_assess_Kids) were entered into G* Power and a two tail “Means: difference between two independent groups” power calculation was performed. With an intervention group mean of 15.94 and standard deviation 9.72; and control group mean 25.79 and standard deviation 11.93 the calculated effect size was 0.9052. To detect this effect size, we need 42 subjects (21 in the intervention group and 21 in the control group) to have statistical power of 0.8 at the significance of 0.05. To account for attrition, this study will aim to enroll 50 children, with 25 in each of the control and intervention groups.

As outlined in the CONSORT statement reporting for RCT’s: between group comparisons will be conducted on intention to treat analysis. Missing data arising from incomplete observations and dropouts will be managed using multiple imputations. Multiple imputations is recommended for use in RCT’s because it avoids bias found in last observation carried forward approaches while maintaining power.
Summary statistics will be reported for each time point for each group using means and standard deviations. For skewed data, medians and interquartile ranges will be reported.

Somatosensory discrimination, goal performance and hand-use: A mixed-effects model with repeated measures will be used to assess within and between group differences. The corresponding baseline measure will be entered as a covariate in the model along with age and somatosensory capacity given these features were used in the randomisation process. The mixed model approach has the advantage of allowing for correlated data (repeated measures) and allows for missing observations within-subject. Model assumptions will be examined and if required transformations applied or non-parametric methods employed. Statistical significance will be set at 0.05.

Cortical change: First-level results from all participants will be pooled into an ANOVA, to investigate (A) changes by time-point, to search for an overall change in brain activation and (B) whether an interaction between time-point and treatment exists.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2018
Actual
Date of last participant enrolment
Anticipated
21/09/2020
Actual
Date of last data collection
Anticipated
20/09/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10249 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 21915 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 298852 0
Government body
Name [1] 298852 0
Telethon New Children's Hospital Research Fund
Country [1] 298852 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
Corner of Winthrop Ave and Monash Ave
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 298051 0
University
Name [1] 298051 0
University of Western Australia, Division of Paediatrics, School of Medicine, Faculty of Health and Medical Sciences
Address [1] 298051 0
Level 4, Administration Building
Princess Margaret Hospital for Children
Roberts Road
Subiaco,WA 6008
Country [1] 298051 0
Australia
Secondary sponsor category [2] 298058 0
University
Name [2] 298058 0
Curtin University, School of Occupational Therapy and Social Work
Address [2] 298058 0
Kent Street,
Bentley, WA 6102
Country [2] 298058 0
Australia
Other collaborator category [1] 279975 0
University
Name [1] 279975 0
Florey Institute of Neuroscience and Mental Health, Stroke Division
Address [1] 279975 0
Melbourne Brain Centre
University of Melbourne
Austin Campus
245 Burgundy Street
Heidlberg VIC 3084
Country [1] 279975 0
Australia
Other collaborator category [2] 279976 0
Government body
Name [2] 279976 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address [2] 279976 0
Australian e-Health Research Centre Level 5 - UQ Health Sciences Building 901/16,
Royal Brisbane and Women's Hospital
Herston, QLD 4029 Australia
Country [2] 279976 0
Australia
Other collaborator category [3] 279977 0
Charities/Societies/Foundations
Name [3] 279977 0
Cerebral Palsy Alliance
Address [3] 279977 0
187 Allambie Road,
Allambie Heights NSW 2100
Country [3] 279977 0
Australia
Other collaborator category [4] 279978 0
Hospital
Name [4] 279978 0
Cincinnati Children's Hospital Medical Center
Address [4] 279978 0
Occupational Therapy and Physical Therapy
3333 Burnet Ave. MLC 4007 Cincinnati, OH 45229-3039 Cincinnati, Ohio USA
Country [4] 279978 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299796 0
Perth Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 299796 0
Perth Children's Hospital
Cnr Winthrop Ave and Monash Ave
Nedlands, WA 6009
Ethics committee country [1] 299796 0
Australia
Date submitted for ethics approval [1] 299796 0
Approval date [1] 299796 0
17/04/2014
Ethics approval number [1] 299796 0
2014034

Summary
Brief summary
Following our feasibility pilot, Sense© training was modified to increase suitability for a paediatric population of children with HCP. The principles of training remain the same and children progress through the same levels of graded somatosensory training as adults. To facilitate child engagement with the Sense© training, the principles of self-determination theory and family centred service were incorporated into the provision of Sense© for Kids training. To improve the relevance of Sense© for Kids training to children with HCP and their families further modifications were implemented following consumer engagement. Focus groups and interviews were conducted and feedback from children and their families were integrated into changes to Sense© for Kids training. A consumer representative also vetted all aspects of the study protocol and details of the intervention. These changes are aimed at reducing the scheduling demands on families and increasing the education provided to parents. Parent coaching will be used to facilitate maximal carryover of the benefits of therapy into everyday life following the completion of the formal intervention period.
Our pilot work suggests that children improve in trained somatosensory domains, motor performance, and in trained occupational tasks. A qualitative investigation of parent and child engagement suggests that improvements were also observed in untrained tasks requiring bimanual function. Improvements following Sense© training were maintained six months after training ceased and warrant further investigation with a larger sample.
In order to test the efficacy of the Sense© for Kids training, a “best practice” comparison intervention will be used to provide adequate control for ‘dosage’ and maintain the external validity of this trial. Further, it is considered unethical to withhold potentially effective interventions in controlled comparison conditions. Goal Directed Training delivered via Home Program is an evidence based intervention with a green light on the traffic light system of evidence for children with HCP. Because there are no evidence based somatosensory discrimination interventions for comparison, Goal Directed Training via Home Program will act as our control. Goal Directed Training is a motor learning approach which uses a child’s goals to allow problem solving and indirectly elicit movements needed to complete a task but does not include any direct somatosensory training: it is therefore a ‘best practice’ control intervention incorporating common features of Sense© for Kids training but no direct somatosensory training.
Our primary objective is to determine whether Sense© for Kids training, a somatosensory discrimination intervention, is more effective than placebo (Goal Directed Training via Home Programs) in improving somatosensory discrimination in children with HCP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81598 0
Mrs Belinda McLean
Address 81598 0
Perth Children's Hospital
Cnr Monash and Winthrop Ave
Nedlands, WA, 6009
Country 81598 0
Australia
Phone 81598 0
+61 8 9380 2119
Fax 81598 0
+61 8 9381 2990
Email 81598 0
[email protected]
Contact person for public queries
Name 81599 0
Dr Ashleigh Thornton
Address 81599 0
Perth Children's Hospital
Cnr Monash and Winthrop Ave
Nedlands, WA, 6009
Country 81599 0
Australia
Phone 81599 0
+61 8 9380 2119
Fax 81599 0
+61 8 9381 2990
Email 81599 0
[email protected]
Contact person for scientific queries
Name 81600 0
Mrs Belinda McLean
Address 81600 0
Perth Children's Hospital
Cnr Monash and Winthrop Ave
Nedlands, WA, 6009
Country 81600 0
Australia
Phone 81600 0
+61 8 9380 2119
Fax 81600 0
+61 8 9381 2990
Email 81600 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23607Study protocolMcLean, B., Blakeman, M., Carey, L., Ward, R., Novak, I., Valentine, J., . . . Harpster, K. (2018). Discovering the sense of touch: Protocol for a randomised controlled trial examining the efficacy of a somatosensory discrimination intervention for children with hemiplegic cerebral palsy. BMC Pediatrics, 18 doi:http://dx.doi.org/10.1186/s12887-018-1217-5   

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDiscovering the sense of touch: Protocol for a randomised controlled trial examining the efficacy of a somatosensory discrimination intervention for children with hemiplegic cerebral palsy.2018https://dx.doi.org/10.1186/s12887-018-1217-5
N.B. These documents automatically identified may not have been verified by the study sponsor.