Table 1 Trial detailed information
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov Identifier: NCT04189159 |
Date of registration in primary registry | 06 December, 2019 |
Source(s) of monetary or material support | The Prompt Institute, USA |
Primary sponsor | The Prompt Institute, USA |
Contact for public queries | SF, MD, PHD simona.fiori@fsm.unipi.it |
Contact for scientific queries | SF, MD, PHD simona.fiori@fsm.unipi.it IRCCS Fondazione Stella Maris, Pisa, Italy |
Public title | PROMPT to Improve Speech Motor Abilities in Children with Cerebral Palsy: a wait-list control group trial |
Scientific title | PROMPT to Improve Speech Motor Abilities in Children with Cerebral Palsy: a wait-list control group trial |
Countries of recruitment | Italy |
Health condition(s) or problem(s) studied | Speech motor intervention in children with cerebral palsy |
Intervention(s) | Active comparator: PROMPT speech motor intensive trial |
Standard care | |
Key inclusion and exclusion criteria | Ages eligible for study: 3–10 years Sexes eligible for study: both Accepts healthy volunteers: no |
Inclusion criteria: infant and children aged 3–10 years; cerebral palsy; speech motor deficit with dysarthria; intellectually adequate or mildly disabled; adequate or mildly impaired comprehension skills; phonatory control/phonate on demand; Italian first or main spoken language | |
Exclusion criteria: exclusive use of alternative augmentative communication; medical fragility of structural/anatomical malformations affecting speech production or preventing participation to intervention | |
Study type | Interventional |
Allocation: randomized intervention model. Single blind (outcomes assessor) | |
Primary purpose: improve speech intelligibility | |
Date of first enrolment | February 2020 |
Target sample size | 60 |
Recruitment status | Recruiting |