Table 1 World Health Organisation required trial registry information
Data category | Information |
|---|---|
Primary registry and trial identifying number | Australian New Zealand Clinical Trials Registry ACTRN12618000348257 |
Date of registration in primary registry | 8/03/2018 |
Secondary identifying numbers | None |
Source(s) of monetary or material support | Telethon New Children’s Hospital Research Fund |
Primary sponsor | Perth Children’s Hospital |
Secondary sponsor(s) | University of Western Australia, Curtin University |
Contact for public queries | Ashleigh Thornton, PhD Ashleigh.Thornton@health.wa.gov.au |
Contact for scientific queries | Belinda McLean, Belinda.McLean2@health.wa.gov.au |
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. |
Countries of recruitment | Australia |
Health condition(s) or problem(s) studied | Cerebral palsy, hemiplegia, impaired tactile discrimination, impaired haptic object recognition, impaired limb position sense |
Intervention(s) | Sense© for Kids somatosensory discrimination training; Goal Directed Therapy via Home Program |
Key inclusion and exclusion criteria | Inclusion: description of hemiplegic cerebral palsy, somatosensory discrimination impairment as measured by sense©_assess kids, aged 6-15 yrs., sufficient concentration to complete assessment. Exclusion: absence of somatosensory impairment fMRI safety exclusion criteria: (metal implants and implantable devices; significant anxiety or behavioural problems; claustraphobia). |
Study type | Single-blind randomised control trial |
Date of first enrolment | Anticipated 17/09/2018 |
Target sample size | 50 |
Recruitment status | Not yet recruiting |
Primary outcome(s) | sense©_assess kids, functional magnetic resonance imaging |
Key secondary outcome(s) | Assisting Hand Assessment, Canadian Occupational Performance Measure, Goal Attainment Scaling. |