An interventional study of PROMPT in Cerebral Palsy and Dysarthria, sponsored by IRCCS Fondazione Stella Maris. Status unknown at 1 site in Italy. Open to participants aged 2 Years to 9 Years. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by IRCCS Fondazione Stella Maris · Not applicable, Interventional, and Treatment
Cerebral palsy (CP) is the most frequent cause of motor disability worldwide, with a prevalence of 2-2.5 per 1000 live births. Children with CP may experience a variety of difficulties with communication including speech. Communication impairment has been identified in at least 40% of children with CP, with 36-90% of CP children experiencing motor speech impairment.
The aims of the current project are to test the effectiveness of intensive PROMPT treatment in a group of preschool children with CP and motor speech disorders (dysarthria/apraxia of speech) and to evaluate differences to the intervention response according to CP type, brain lesion severity and white matter integrity of corticospinal tract. We hypothesize that children with CP and motor speech disorders will benefit from 3 weeks of daily administration of PROMPT treatment and show measurable improvement of speech intelligibility on clinical and kinematic assessments, with 3 months stability. Outcome measures will include a standardized speech motor assessment as well as improvement in kinematic speech measures detected by a computerized system. We also hypothesize that children with dyskynetic CP will show more improvement induced by the PROMPT treatment as compared to children with spastic CP. We finally hypothesize that corticospinal microstructural integrity positively impact on intelligibility recovery, with children with better integrity having bigger improvements.
Our study of PROMPT with children with varying types of CP meets current international priorities of testing and implementing effective, earlier interventions, therefore investing in the improvement infant's health based on evidence, as a future investment for individuals and the community.
Research questions/Hypothesis Aim 1: To test the effectiveness of intensive PROMPT treatment in a group of preschool children with CP and motor speech disorders (dysarthria/apraxia of speech).
Aim 2: To evaluate differences to the intervention response according to CP type, brain lesion severity and white matter integrity of corticospinal tract.
Primary Hypothesis: children with CP and motor speech disorders will benefit from 3 weeks of daily administration of PROMPT treatment and show measurable improvement of speech intelligibility on clinical and kinematic assessments, with 3 months stability.
Secondary hypotheses: children with dyskynetic CP will show more improvement induced by the PROMPT treatment as compared to children with spastic CP. Investigators also hypothesize that children with less severe brain lesions will have a higher level of improvement compared to children with more severe brain lesions. Investigators finally hypothesize that corticospinal microstructural integrity positively impact on intelligibility recovery, with children with better integrity having bigger improvements.
Because PROMPT has been shown to be beneficial in several older children with CP, investigators' rational for the design allows for achievement of the RCT data collection and analysis, as well as allow all identified and consented children to receive the intervention.
The participants will include children between 3 and 9 years of age, with a diagnosis of CP and speech motor disorders. Parents will be asked to consent for the children for the participation in the study. All study activities will be carried out in our clinical center setting with a PROMPT trained therapist with appropriate knowledge of clinical research process.
In investigators' studies of rehabilitation with the CP population consent to participate in studies approaches 90%. From investigators' experience and clinical demographics of the center, they were expected 30 patients diagnosed CP with speech difficulties in the requisite age group per year, making possible a design of staggered enrollment of intervention and wait-list-control groups in the RCT. Recruitment will be completed according to the standards of research consent, followed by group randomization, by a team member other than the treating therapist. The assessments will be completed by an experiences SLP, different from the treating therapist.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 60 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →IRCCS Fondazione Stella Maris is the lead sponsor of 46 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PROMPT treatment, twice a day, for 5 days a week, for 3 consecutive weeks
Behavioral: PROMPT
Usual treatment
PROMPT treatment is consistent with the principles of motor learning, in that every session includes a blocked pre-practice followed by variable and distributed practice and a gradual, hierarchical increase of complexity. Speech motor goals are integrated in goals for language and functional communication. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided, in order to shape speech movements, to give information on sequencing and timing and to introduce constraints for the reduction of degrees of freedom at the articulators' level in favour of motor control.
Also known as: motor speech treatment
Verbal Motor Production Assessment for Children (VMPAC)
Standardized motor speech assessment, which includes 5 subscales, where higher scores mean better performance: Global motor control (range 20-0); Focal oromotor control (range 268-0); Sequencing (range 46-0); Connected speech and language (range 45-0); Speech Characteristics (range 7-0)
Time frame: after the end of treatment period (4 weeks from baseline)
Phonetic Inventory
motor speech measure
Time frame: after the end of treatment period (4 weeks from baseline)
the Intelligibility in Context Scale - Italian version
motor speech measure, range 1-5, where higher scores mean better performances
Time frame: after the end of treatment period (4 weeks from baseline)
Viking Speech Scale (VSS)
Ordinal scale for intelligibility, range 1-4, with lower scores corresponding to better performances
Time frame: after the end of treatment period (4 weeks from baseline)
kinematic speech motor measures
A kinematic analysis of facial movements during simple speech repetition tasks
Time frame: after the end of treatment period (4 weeks from baseline)
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IRCCS Fondazione Stella Maris