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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]

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

Hemiplegia

Impaired tactile discrimination

Impaired haptic object recognition

Impaired limb position

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

sense©_assess kids- sensory discrimination measure

Timepoint [1]

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]

Functional Magenetic Resonance Imaging will be used to measure changes in neural pathways following treatment.

Timepoint [2]

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]

Changes in aspects of activity performance will be measured using the Assisting Hand Assessment.

Timepoint [1]

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]

Changes in occupational performance are being measured using the Canadian Occupational Performance Measure and Goal Attainment Scaling

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Telethon New Children's Hospital Research Fund

Address [1]

Research Development Unit
Level 2, Block C
Department of Health
189 Royal Street
East Perth, WA, 6004

Country [1]

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]

University

Name [1]

University of Western Australia, Division of Paediatrics, School of Medicine, Faculty of Health and Medical Sciences

Address [1]

Level 4, Administration Building
Princess Margaret Hospital for Children
Roberts Road
Subiaco,WA 6008

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

Curtin University, School of Occupational Therapy and Social Work

Address [2]

Kent Street,
Bentley, WA 6102

Country [2]

Australia

Other collaborator category [1]

University

Name [1]

Florey Institute of Neuroscience and Mental Health, Stroke Division

Address [1]

Melbourne Brain Centre
University of Melbourne
Austin Campus
245 Burgundy Street
Heidlberg VIC 3084

Country [1]

Australia

Other collaborator category [2]

Government body

Name [2]

Commonwealth Scientific and Industrial Research Organisation (CSIRO)

Address [2]

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]

Australia

Other collaborator category [3]

Charities/Societies/Foundations

Name [3]

Cerebral Palsy Alliance

Address [3]

187 Allambie Road,
Allambie Heights NSW 2100

Country [3]

Australia

Other collaborator category [4]

Hospital

Name [4]

Cincinnati Children's Hospital Medical Center

Address [4]

Occupational Therapy and Physical Therapy
3333 Burnet Ave. MLC 4007 Cincinnati, OH 45229-3039 Cincinnati, Ohio USA

Country [4]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Perth Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

Perth Children's Hospital 
Cnr Winthrop Ave and Monash Ave
Nedlands, WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/04/2014

Ethics approval number [1]

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

Mrs Belinda McLean

Address

Perth Children's Hospital
Cnr Monash and Winthrop Ave
Nedlands, WA, 6009

Country

Australia

Phone

+61 8 9380 2119

Fax

+61 8 9381 2990

Belinda.Mclean2@health.wa.gov.au

Contact person for public queries

Name

Ashleigh Thornton

Address

Perth Children's Hospital
Cnr Monash and Winthrop Ave
Nedlands, WA, 6009

Country

Australia

Phone

+61 8 9380 2119

Fax

+61 8 9381 2990

Ashleigh.Thornton@health.wa.gov.au

Contact person for scientific queries

Name

Belinda McLean

Address

Perth Children's Hospital
Cnr Monash and Winthrop Ave
Nedlands, WA, 6009

Country

Australia

Phone

+61 8 9380 2119

Fax

+61 8 9381 2990

Belinda.Mclean2@health.wa.gov.au

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

Source	Title	Year of Publication	DOI
Embase	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.	2018	https://dx.doi.org/10.1186/s12887-018-1217-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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