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Discovering the sense of touch- somatosensory discrimination training for children with cerebral palsy

Discovering the sense of touch: A randomised controlled trial examining the efficacy of a somatosensory discrimination intervention for children with hemiplegic cerebral palsy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000348257
Enrollment
50
Registered
2018-03-08
Start date
2018-09-17
Completion date
2020-09-21
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Perth Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of Cerebral palsy Hemiplegia Somatosensory discrimination impairment as measured by the sense_assess Aged 8-15yrs Sufficient concentration to complete assessment

Exclusion criteria

Absence of somatosensory impairment fMRI safety exclusion criteria (metal implants and implantable devices; significant anxiety or behavioural problems; claustraphobia)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026